Evidence of meeting #8 for Health in the 40th Parliament, 3rd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was facility.

A recording is available from Parliament.

On the agenda

MPs speaking

Also speaking

Bill Cameron  President, Canadian Association for HIV Research
Rainer Engelhardt  Assistant Deputy Minister, Infectious Disease Prevention and Control Branch, Public Health Agency of Canada
Donald Gerson  President and Chief Executive Officer, PnuVax Inc.
Rafick-Pierre Sekaly  Co-Director and Scientific Director, Vaccine and Gene Therapy Institute Florida
Steven Sternthal  Head, Canadian HIV Vaccine Initiative Secretariat, Director, Office of HIV Vaccines, Public Health Agency of Canada

9:05 a.m.

Conservative

The Chair Conservative Joy Smith

Ladies and gentlemen, I'd ask you to take your seats. I'd like to start the committee now.

Dr. Cameron, I heard that you were held up coming in through security. Is there anything I should know before we start?

9:05 a.m.

Dr. Bill Cameron President, Canadian Association for HIV Research

It was actually the Pretoria Street Bridge.

9:05 a.m.

Conservative

The Chair Conservative Joy Smith

Well, if it's any comfort, they attempted to hold me up too, until they realized, whoops, I could come in.

Pursuant to Standing Order 108(2), we are studying the cancellation of the HIV vaccine manufacturing facility, under the Canadian HIV vaccine initiative.

I welcome our witnesses here this morning. We're going to give you five minutes for your presentation, and then after that we're going to be going into a seven-minute question and answer period for you as well.

I think I'm going to start with Dr. Rainer Engelhardt. Could you start the presentation, please, Dr. Engelhardt?

9:05 a.m.

Dr. Rainer Engelhardt Assistant Deputy Minister, Infectious Disease Prevention and Control Branch, Public Health Agency of Canada

Madam Chair, thank you very much.

Members of the committee, thank you for this opportunity to discuss the Canadian HIV vaccine initiative.

As assistant deputy minister of the infectious disease prevention and control branch with the Public Health Agency in Canada, I'm responsible for the development and implementation of national public health strategies to address really a range of infectious diseases, including influenza, pandemic and otherwise, hepatitis, tuberculosis, and HIV/AIDS.

Through partnerships with Canadian and international scientific public health and community organizations, the agency takes a leadership role in mobilizing a comprehensive response to HIV/AIDS. This includes research, surveillance, epidemiology, broad spectrum, including the development of new prevention technologies and specifically a vaccine for HIV/AIDS.

In February 2007, the Prime Minister and Mr. Bill Gates announced a collaboration between the Government of Canada and the Bill and Melinda Gates Foundation.

This collaboration's main goal was to help speed up the global development of an HIV vaccine, which is our greatest hope for overcoming the HIV/AIDS epidemic worldwide. Altogether, funding of $111 million was provided by the Government of Canada and $28 million from the Gates Foundation was dedicated in support of this collaboration.

To achieve the important goal of developing a vaccine, in 2007 the Government of Canada established the Canadian HIV vaccine initiative. That brings together five federal departments and agencies: the Canadian International Development Agency, the Public Health Agency, Industry Canada, Canadian Institutes of Health Research, and Health Canada. Each shares a commitment to position Canada at the forefront to develop this HIV/AIDS vaccine.

My agency helps to ensure a coordinated effort among the departments, and currently houses the secretariat for the initiative. I'd like to note that I'm joined here today by Mr. Steven Sternthal, who is the director of the agency's office of HIV vaccines and is responsible for the initiative's secretariat.

The initiative is aligned with priorities established by the Global HIV Vaccine Enterprise in 2005.

The Enterprise's global scientific plan followed global consultations, which identified some key obstacles that were facing researchers in vaccine development, and specifically the initiative has focused on four key program areas.

On the first area, discovery and social research, funding is being provided to support HIV discovery and the social research components thereof. We strengthen the research and capacity in Canada, as well as in low- and middle-income countries. Under that, 13 discovery and social research projects are currently in place on HIV vaccines, totalling a commitment of nearly $3 million. A single example, and an interesting one, is that McGill University has received $440,000 to learn about the special characteristics of immune cells in certain people exposed to HIV but who remain uninfected. There are additional research funding opportunities that are funded under that program.

A second key program is the clinical trials capacity building and networks, through which funding is being provided to researchers and to research institutions, particularly, again, in low- and middle-income countries, to strengthen their capacity to conduct high-quality clinical trials on HIV, and HIV vaccines in particular, and other related prevention technologies. A request for applications for clinical trial capacity building is currently under way for Africa, and the results of these trials are supposed to be released by 2010.

The third program area is for the policy and regulatory issues, community and social dimensions, through which funding is provided to strengthen vaccine policy approaches that promote global access to HIV vaccines, regulatory pathways and processes for the vaccines in low- and middle-income countries that can be enhanced through capacity-building initiatives, and, again, community involvement in vaccine research and development, clinical trials, and activities in public awareness and education related to them.

Currently, there are two HIV community initiatives under way and two international initiatives that have been completed, totalling more than half a million dollars, including, for instance, the Canadian AIDS Society, which is receiving $268,000 under this program. Also, just to note, $760,000 has been provided to the Global HIV Vaccine Enterprise's renewal of the global scientific strategic plan, and an additional $2 million is being provided to the World Health Organization to improve the capacity of regulatory authorities in Africa.

I'd like now to turn to the HIV vaccine manufacturing project under the initiative. The primary reason for launching this project was to address a global shortage of pilot-scale manufacturing facilities for an HIV vaccine, as identified by the Global HIV Vaccine Enterprise in 2005. Given the importance of addressing this global gap identified at that time, the establishment of the facility became an initial priority for the Canadian HIV vaccine initiative. Consultations were held in late 2007 by the Government of Canada and the Gates Foundation to seek the input of experts to design the most appropriate process to establish a facility here in Canada. Based on this consultation, a call for letters of intent was launched in April 2008 to seek the interest of not-for-profit organizations and their potential partners. During these consultations, it was also decided that a minimum of two months would be needed to put together a letter of intent and an additional four to five months would be needed to put together a full application. These letters of intent were received in June of 2008 and were subject to a thorough review, and based on that review, it was decided by the Government of Canada and the Bill Gates Foundation that four applicants should be moving forward to develop a full application. That was announced in November of 2008 and those applications were received in March of 2009.

I understand there were several questions from committee members regarding the process that was undertaken to review the applications, as well as how the decision not to move forward with the facility project was made. I'd like therefore to take this opportunity to clarify just a few points.

As Dr. Butler-Jones has previously noted in his appearance before this committee on March 16 and 18, a thorough and comprehensive review process was put in place to assess each of the applications. Key international experts were brought in to assess the scientific merit of the applications. These experts, just as a sidebar comment, were highly qualified in HIV vaccine research, facility construction and operation, governance, and financial management.

Also, officials from the Government of Canada and the Gates Foundation undertook their own due diligence, focusing on two key areas: value for money and applicant risk, meaning the sustainability and feasibility of the proposals. The end result was that the review process found that all four applications had strength in their applications. But overall, it also found that none of the four applications met all of the pre-established criteria, which was a difficult finding on our part. To ensure, then, that full and complete applications would be submitted and considered, the Government of Canada clearly outlined, in the invitation to submit the application, the necessary requirements as stipulated in the terms and conditions.

I want to stress that the criteria assessed in the review were shared with all applicants at the outset of the process.

In a separate process, the Gates Foundation commissioned a study that analyzed the current HIV vaccine manufacturing capacity in North America and Europe. That study, by Gates, concluded that at that time, sufficient manufacturing capacity had become available to support the anticipated demand for pilot-scale manufacturing of candidate HIV vaccines. That capacity study was made available to us in late July 2009.

As the overall endeavour of facility construction is certainly costly--potentially valued at $88 million--it was our responsibility to ensure that there was value for money for Canadian taxpayers. It was after careful consideration and much discussion that the Government of Canada and the Gates Foundation decided, as you know, not to proceed with the vaccine manufacturing facility.

I want to reiterate what Dr. Butler-Jones stated, which is that at the end of the day, the decision not to move forward with the facility, which was not an easy decision, was based on purely scientific and technical considerations.

Although the facility project was not moving forward, I'd like to say that there have also been significant benefits arising from collaboration with the Gates Foundation. Through working with the foundation, the Government of Canada has been able to leverage the foundation's scientific excellence as well as its worldwide connections and experience in this field.

The collaboration has allowed us to further strengthen our strong Canadian foundation in biomedical science, technology innovation, and vaccine research.

Moving forward, the Government of Canada remains committed to fighting HIV and AIDS. In support of this, the government and the Gates Foundation will continue to work together. They have reiterated their financial commitment to supporting HIV prevention.

In summary, both parties remain committed to accelerating the development of a safe, effective, accessible, and, importantly, affordable HIV vaccine as one of their key priorities.

Thank you very much.

9:15 a.m.

Conservative

The Chair Conservative Joy Smith

Thank you so much.

We'll now go to Dr. Bill Cameron from the Canadian Association for HIV Research.

9:15 a.m.

President, Canadian Association for HIV Research

Dr. Bill Cameron

Thank you, Madam Chairman.

9:15 a.m.

Conservative

The Chair Conservative Joy Smith

Dr. Cameron, do you have a copy of your presentation? I don't have it in front of me. If you could submit it to the clerk, we'll get it translated and distributed to everybody.

9:15 a.m.

President, Canadian Association for HIV Research

Dr. Bill Cameron

I will, and it will be brief.

9:15 a.m.

Conservative

The Chair Conservative Joy Smith

Thank you.

9:15 a.m.

President, Canadian Association for HIV Research

Dr. Bill Cameron

My name is Bill Cameron. I'm a professor of medicine at the University of Ottawa, Ottawa Hospital, and I am speaking as the president of the Canadian Association for HIV Research, which had a large professional and academic interest in the proposal that was nicely described, if not the process of its creation and deconstruction.

Vaccine development nowadays is a complex and highly regulated process. I have a professional history myself in vaccine development in the pre-clinical area, where in animal models of infection I can provide a rabbit very good protection against an infectious disease--so of no interest to rabbits, only to humans. I cannot, as an academic and a clinical investigator, bring this forward into human beings without the good laboratory practice that is required. It is largely a documentary process for regulatory approval to bring a vaccine candidate or a vaccinogen into human clinical trials.

This is not going to happen in our lifetime. There is no economic model that makes sense to do this—it's just the right thing to do. And it's not going to happen because our corporate structures, our industries, and our private sector do not have the business model to make this a solvent exercise. Never mind intellectual property, it's the cost of the process of bringing a vaccinogen forward into human trials. It is unmet by industry. If this is in the public interest, we are going to require public funds to bring this forward. Private funds will not do so.

So if not our country through our government, then who? We can go asking for charity or we can ask our government to bring forward this opportunity. I would say that scientifically and technically we are at the edge of a golden age in infectious diseases and vaccines for prevention, for public health, that we have never had before. We have, in the same time, put forward an enormously complex, highly regulated, and expensive process for doing so, so much so that it will take $100 million to bring forward a vaccine candidate to the point of regulatory approval. If this is not going to come about through industry, then it has to come about through the public sector in some manner.

This explains why, as academic and professional or scientific investigators in vaccine development, we were so unhappy with the decision. We don't question the process. There were criteria—

9:15 a.m.

Conservative

The Chair Conservative Joy Smith

Dr. Cameron, would you address the chair, not Dr. Engelhardt? Thank you.

9:20 a.m.

President, Canadian Association for HIV Research

Dr. Bill Cameron

Of course. I appreciated Dr. Engelhardt's presentation very much. I apologize, Madam Chair.

I appreciate those difficulties, so I polled the heavies at the Canadian Association for HIV Research, and we have a consensus statement to make.

Industrial vaccine production capacity is a useful resource for industrial needs of corporations. On the other hand, if the public interest in vaccine research is to be met, public funding and accessibility of good laboratory production facilities are needed for investigator-driven vaccine research. These needs are not going to be met by corporate and private interests; they must be met by public interests if we are to serve the public's needs.

Twenty years ago, the Medical Research Council of Canada told clinical researchers who were interested in conducting clinical trials to go to industry, that the MRC did not have funds to support clinical trials; these were done by industry. We discovered very quickly that industry does not meet or serve the public interests or the academic interests in clinical research. They make pills to sell.

CIHR, the reincarnation of the Medical Research Council, has since learned to fund randomized controlled trials—clinical trials—publicly. We have established a very productive Canadian HIV clinical trials network to actually execute investigator-driven clinical trials, which are conducted in order to serve the health care needs in management, not just in new drugs, for clinical trials in HIV. This was a necessary and fruitful step. It came from the public sector. It did not come from industry.

The same is true now in vaccine research. If we are going to have the capacity to take investigator-driven discovery and invention that our universities are capable of away from bunny rabbits and into human beings under good regulatory surveillance, we need the public funds to support GLP—good laboratory practice—facilities for production of vaccine candidates suitable for human clinical trials. This is a requirement. It's not going to come from industry.

When this study shows us that the capacity to produce vaccine candidates who might be put forward by industry is met in industry, that same capacity does not address the creativity of discovery that will come from academic and scientific endeavours at our universities. This is a large potential contribution. Its potential in discovery is greater than what can be pursued in industry in the sense that it is more diverse and there is more risk taken.

We do not have the candidate HIV vaccine right now. We need to discover it, and it's going to be discovered in human clinical trials. Right now, we have several under way, but they're huge. They cost hundreds of millions of dollars and they are conducted according to the corporate and industrial agenda. If we want discovery and we want to tap our universities' capacity, we will have to provide a little bit of the industrial capacity to those researchers--not through industry; it doesn't work that way. It has to be provided from the public sector.

Thank you.

9:20 a.m.

Conservative

The Chair Conservative Joy Smith

Thank you very much, Dr. Cameron.

We'll now go to PnuVax Incorporated, Dr. Donald Gerson, president and chief executive officer.

9:20 a.m.

Dr. Donald Gerson President and Chief Executive Officer, PnuVax Inc.

Hello. My name is Don Gerson, and I've been involved in manufacturing vaccines for the last 25 or more years. I've produced, under my direction, over 3.5 billion doses of vaccine, some in Canada as head of manufacturing at Connaught Labs and some at other companies around the world.

The thing that I think it is important to understand, in addition to what Dr. Cameron just said, is that right now the HIV epidemic is still growing. It's growing rapidly: nine or 10 people are being infected daily in North America. The demographics are, I'm going to say, universal and ubiquitous. It's not distinguished between one place or another, one person or another. Everyone who gets HIV dies of it. We have not had many epidemics of that nature, possibly except for tuberculosis. This epidemic needs to be stopped or it will basically kill all of us. That's just reality.

I want to talk a little bit about the problem that this facility was intended to address. The important thing, I think, that is hard to understand, unless you've been there and done it—which I have for a very long time—is the exquisite nature of the facilities and the procedures that are required to make a vaccine that's going to be injected into a human being.

You put a small volume of liquid into the person, but you can't get it out again. You have to make it under extreme conditions of care. The facility has to meet not just the government requirements but the industry requirements and the practical requirements, to make sure there is nothing that should not be in it: not a particle that is half a micron in diameter, not some other virus or another living organism, not some chemical that shouldn't be there. This is a massive amount of work, and you can't just do it in a university lab. University labs are meant for discovery.

You can't just do it—I'm going to add one layer—in a GLP facility. That's good, but not good enough. So you have to have a facility where everything is not just clean but proven to be clean, where every chemical is not just a chemical but proven to be the chemical you intend it to be. This is tough stuff, and it's also very hard to expand the work from the laboratory into, first, the larger-scale production of making a few thousand doses for a clinical trial, and second, expanding that into a production of making millions or billions of doses of a vaccine for human consumption.

Particularly with HIV vaccines--I've worked on many, a dozen or so, at various different organizations, and I have seen a number fail because of the failure to follow good manufacturing practices. That was actually the origin of this. I've produced a very large report for the international AIDS vaccine initiative in about 2003, which went to the Gates Foundation, which said that they had been running all over the world looking for facilities of this nature and had had a very hard time finding those that met the requirements. They also said they have had a number of vaccines that have failed because of what somebody else might consider to be minor aspects of contamination or documentation failure but that make the outcome of the clinical trial useless.

The clinical trial comes after $100 million, $200 million, $300 million, or $400 million worth of work. In fact, for the final vaccine—the last vaccine that I produced in the United States was for smallpox after the 9/11 incident—we made a new process for the vaccine: totally new vaccine, 300 million doses, $800 million.

The previous vaccine was for childhood pneumonia. It took 10 years. I took it through the last five years, and it cost almost $1 billion to make the first dose of commercial vaccine. It made money back eventually, but this is tough stuff. You can lose the whole investment by having poor-quality clinical materials. That's what this facility was about.

The other topic I'd like to talk about is the following. One of the various comments made about why this was cancelled was that none of the facilities was economically sustainable. I take serious exception to that. First, while the Oliver Wyman report, which was just shown to you all, says there are lots of facilities, it also says on the first page that they didn't take quality into account, which ignores all of what I just told you.

Second, the concept that a clinical facility operating as a CMO, a contract manufacturing organization, could not make money and be self-sustaining is a conclusion that I think you could only come to if you haven't done it. I've done this many times. I set up the Alberta Research Council's biotechnology pilot plant, which was many millions of dollars in investment and which I ran at a profit in the eighties. I've done other such things time and time again, and so have other people. You can make a very good profit. In the last four years, just before returning to Canada, I set up a contract manufacturing company in Korea. We invested $250 million in a 50,000-litre facility for making monoclonal antibodies. We started cold. We started in a country that had essentially no such industry and we ran it at a profit. The $250 million investment is now a company worth $1.4 billion. It employs 300 or 400 people, and it's a going concern and will continue to be so. So whether it's large or small, this can be done.

The conclusion that this is not profitable either comes from someone who doesn't know how to do this or from someone who does not want it done because it's competition. That's part of the business world too. I think it's important to say, however, that the process by which the evaluation was done, the format that was used or the approach taken, was fine. There were no problems there. It was a little slow to my way of thinking, but maybe I'm not used to government. That's not where the flaw was in this. There's some decision-making process that has deprived Canada of an important facility that could have been a nucleus for economic development, that could have been a source for trial vaccines that could have used Canadian expertise in this field to develop the vaccine for HIV, which is critically important not only to Canada and to the use of huge investment in Canada in infectious diseases, but also to stop an epidemic that could kill every person on earth.

Thank you.

9:30 a.m.

Conservative

The Chair Conservative Joy Smith

Thank you very much for your presentation.

We have one more presenter.

I'm Joy Smith, the chair of this committee, and thank you for making it here.

By video conference, from the Vaccine and Gene Therapy Institute in Florida, we have Dr. Rafick-Pierre Sekaly, co-director and scientific director. Doctor, you have between 5 to 10 minutes. I've been giving people extended time so they can finish their presentations. If you would go ahead and make your presentation to the committee, it would be very much appreciated.

9:30 a.m.

Dr. Rafick-Pierre Sekaly Co-Director and Scientific Director, Vaccine and Gene Therapy Institute Florida

I just heard what the previous presenter mentioned. I moved to Florida about a year ago. I was initially very much involved as scientific director of the Canadian vaccine network. It was funded by the national centres of excellence to promote the development of the potential collaboration with the Gates Foundation. Some time in October 2003, Dr. Plummer, Dr. Singh, who was at the time the head of the infection immunity institute of CIHR, and I all went to meet the Gates Foundation and entertain the possibility of developing a joint centre between the Gates Foundation and Canada on the development of an HIV vaccine. So that's the way things started.

There was a very good response by the Canadian government at the time. By 2007 there was a signed agreement between the Prime Minister and Bill Gates regarding this mega-collaboration.

I was very much involved in putting together the strategic plan of the Global HIV Vaccine Enterprise. It is a network of independent institutions, including CIHR. All of those institutions are focused on developing a vaccine for HIV. Each one provides their expertise and contributes toward establishing an HIV vaccine. Let's say some place in the U.S. provides some pre-clinical work. In this global HIV enterprise, everybody brings a contribution.

Because there was a very well-identified paucity in vaccine-lot production, we thought of Canada specifically, especially with companies like GSK and Sanofi Pasteur that had vaccine production plants here in Canada. We thought that would be a very significant contribution from Canada. In fact, during those discussions, Sanofi Pasteur was very much involved. At the end they pulled out of the game, but we still managed to put together four very important proposals that were very well reviewed. They highlighted the Canadian expertise in vaccine development, from the basic research to the pre-clinical development, all the way to clinical production. I think the availability of this vaccine-lot pilot plant is going to be a catalyst in fostering Canadian expertise, improving it, and attracting top-notch investigators.

As I mentioned in the press when that decision was made, unfortunately it was a missed opportunity. We went through the whole process, which lasted almost two years, where people really invested a lot of their time and effort and brought highly credible proposals to the table, but in the end everything just fizzled out for reasons I'm still trying to figure out.

It's a missed opportunity, not only because I think Canada has to make a contribution toward HIV vaccine development. You all know that for the past year we've been hit with this swine flu. When we were discussing putting together a vaccine production plant, it was very clear that there was going to be a focus on HIV, but the vaccine plant was also going to be available for any emerging disease epidemic.

When we were talking about this, it was about bio-events. There was all the talk about anthrax and pox, so we all agreed that it was also going to be available in case Canada faced that kind of epidemic. You all know that last year we were grappling with the possibility that you might be hit with a swine flu epidemic. We were all very worried about when the vaccine was going to be ready, and we know there were delays in testing the vaccine to make sure it was safe. Having a facility like this one would certainly help accelerate the implementation of a vaccine for the Canadian population.

At the end of the day, I think the decision is questionable on multiple fronts. First, it fails to put together a cohesive network of scientists, all the way from basic research to clinical development to clinical trials.

Second, I think Canada has to contribute to HIV vaccine development, as Don Gerson mentioned. I think it's a moral obligation that you owe the world community. We have committed to doing this, and I don't understand why we have backtracked.

Third, having this facility would help not only HIV vaccine development; it was meant to be available for any epidemic. That means that Canada was going to be independent from GSK or other companies that might take time to develop a vaccine or might make a decision not to eventually develop a vaccine for a specific disease. That was going to put us in a position of being independent of having other people making decisions for us.

Those three reasons, again, make you question the validity of the decision. I really would like to understand why the decision was made. I would like to contribute to any path that might lead to reversing the decision or convincing the government that the decision has to be modified.

9:40 a.m.

Conservative

The Chair Conservative Joy Smith

Thank you so much, Dr. Sekaly.

As you know, now we're going to seven-minute rounds. I'm going to be very tight on the time, the reason being that I want to get in as many questions and as many answers as we possibly can.

At the end of the meeting, I'm going to go into the business part. We just have to quickly get a budget to cover witness expenses at meetings.

Starting now, we'll have seven minutes for the question and the answer, and we'll start with Dr. Duncan.

9:40 a.m.

Liberal

Kirsty Duncan Liberal Etobicoke North, ON

Thank you, Madam Chair, and thank you to the witnesses.

I guess I'm struggling. We hear that we need this. We hear that it was a two-year process. We hear your frustration. What happened? I think it's important that we look at the process.

9:40 a.m.

Conservative

The Chair Conservative Joy Smith

Excuse me. The feed is coming in from a different conversation.

We will start again with Dr. Duncan.

9:45 a.m.

Liberal

Kirsty Duncan Liberal Etobicoke North, ON

I guess I'm struggling with what we hear. We hear that this was a two-year process, and yet the decision is questionable on multiple fronts. It was a missed opportunity, and people want to understand what happened. I'm really hoping that we can get past the government talking points, namely that the Gates Foundation study found that there was excess vaccine capacity and that none of the applicants qualified.

With respect, to avoid running out of time, I will be asking yes and no questions, and I'll ask for elaboration if needed. I think I'd like to address these to Dr. Sternthal.

After the technical assessment was complete, was there one applicant that was ranked ahead of the others, yes or no?

9:45 a.m.

Steven Sternthal Head, Canadian HIV Vaccine Initiative Secretariat, Director, Office of HIV Vaccines, Public Health Agency of Canada

The exploratory process did have assessments that found strengths and weaknesses for all the applications.

9:45 a.m.

Liberal

Kirsty Duncan Liberal Etobicoke North, ON

With respect, please give a yes or no answer.

9:45 a.m.

Head, Canadian HIV Vaccine Initiative Secretariat, Director, Office of HIV Vaccines, Public Health Agency of Canada

Steven Sternthal

I can't answer that question with a yes or no.

9:45 a.m.

Conservative

The Chair Conservative Joy Smith

Dr. Duncan, let's give him the latitude of adding a few words. He'll be as concise as he can.

Please continue, Dr. Sternthal.

9:45 a.m.

Head, Canadian HIV Vaccine Initiative Secretariat, Director, Office of HIV Vaccines, Public Health Agency of Canada

Steven Sternthal

Sure, but I'm not a medical doctor.

The applications were all assessed, and there were strengths and weaknesses identified for all four applications. Some had different strengths and different weaknesses and some had more strengths and more weaknesses. That information was used as part of the overall assessment and review.