Any doubts that Pfizer would have had the "spade in the ground" last March with apabetalone and this Phase 2 clinical trial?

Argue the whole system isn't rigged, crooked, along with a few other agendas!

Like you, wondering how long they'll stall this part! Poor Don, hopefully the EVERSANA folks left their BP positions because they couldn't stomach what they saw and heard...and are really rallying behind us as best they can!

Bourla just can't contain himself....

Pfizer To Submit Covid Pill To FDA Before Thanksgiving

Nov 06, 2021 (MENAFN via COMTEX News Network) -- (MENAFN - ValueWalk

Following is the unofficial transcript of a CNBC interview with Pfizer Inc. (NYSE:PFE) Chairman and CEO Albert Bourla on CNBC's"Squawk Box" (M-F, 6AM-9AM ET) today, Friday, November 5th. Following is a link to video on CNBC.com:

All references must be sourced to CNBC.

ANDREW ROSS SORKIN: Welcome back to"Squawk Box." We're going to get straight over to Meg Tirrell who has a special guest this morning with some big news. Meg.

MEG TIRRELL: Absolutely Andrew, joining us now is Albert Bourla , the CEO of Pfizer. Albert, long time no see. We just talked to you now on Tuesday but now the world has changed. You've reported these just amazing results on your COVID antiviral drug that Pfizer developed in house. Tell us your expectation for what a drug like this, 89% reduction in hospitalizations and deaths, could do for the pandemic.

ALBERT BOURLA: Of course, it's a game changer, Meg. This is a fantastic demonstration of the power of science and in fact it's coming all a year almost to the date since we announced the results of the previous breakthrough the vaccine with 95% efficacy, right. So it was in the November 9th and now it is November 5th. I think this medicine will change the way things are happening right now that will save millions and millions of lives. It has the potential to do it.

TIRRELL: Wow. Tell us about just how quickly you think you can file with the FDA. Merck has an advisory committee meeting coming up November 30th. Could we be seeing back to back advisory committees that quickly potentially your drug available potentially that soon?

BOURLA: You know I can't speak about the FDA and what they plan to do is they plan to have advisory committees and how fast they will do it. We plan to submit quite fast likely plan to submit before the Thanksgiving holiday so then it's up to FDA to review the data. We plan to do the same with other regulatory authorities in the world. We'll do it very fast.

TIRRELL: I see, before Thanksgiving filing. Tell us about supply. We know you've invested a billion dollars at risk to make sure that this could be ramped up. How much will you have this year and next year and tell us about just the any supply agreements you've already struck?

BOURLA: Yes actually we've invested a bit more than $1 billion, $1.2 so far, but we've we have a capacity right now of 500 million pills which means 50 million treatments, right. So, it is one, a two pills per day, one for five days the course of treatment. So, we'll have for '22 around 50 million of that. Now of course we realize that very high efficacy comes even to us as a surprise exceeds our most visionary expectations we have for that. We are jumping immediately to see what more can we do in, in manufacturing supply.

JOE KERNEN: Meg that, that was obviously the question to ask, what we're talking about and that's fast. I didn't know the panel meeting, Albert, was, was going to be at the end of this month so that could be before the end of this year. I'm going to ask very gently. Andrew, I don't wanna, I don't want you to get upset about, about this but if the world has a pill that does this, is there any way that lessens the, the very divisive mandate question that we talk about everyday that's January 4th and you make a vaccine too a great vaccine as well, Albert. And I think everybody should be vaccinated, but we're seeing that you're hitting some, some walls on getting above these percentages and we have, you know, sad cases where employees are actually fired in for not, you know, for not agreeing to take the vaccine. Will there come a time where the vaccine mandates become not mandates, Albert, because we have a therapeutic that takes the worst case scenario off the table?

BOURLA: First of all, very good question, but it's not me that I'm deciding the mandates or not. It's the health authorities that they take into consideration, the health, the public health and the public interest. From my perspective, I want to say that the, the fact that we have a treatment is not at all a reason not to take the vaccine. In fact, we should take the vaccine. Someone unfortunate will get the disease and that's the good news is that we have now treatment that can reduce hospitalizations instead of 10 people going to hospitals , only one will go. This is basically what the results are telling us and likely very few will die if any if they take the medicine. So, this is important, but this is for people that already they get the disease. This is for sick people. If the goal here is to prevent people from getting sick.

KERNEN: And the vaccine will never be perfect because it depends on the response of someone's immune system to, to the antigen, obviously so to have something that attacks the virus itself instead of, you know, depending on a compromised person's body to defend it is a huge step. It's a big difference and it brings in a whole new group of people that could benefit from, from taking a pill or getting a vaccine. It's fantastic.

BOURLA: Absolutely. You're absolutely right.

TIRRELL: I've got another question for you Albert. Just going back to the supply question the New York Times has reported this morning that the US government is in talks with Pfizer to supply 1.7 million courses with an additional option for another 3.3 million at a similar price to Merck's Molnupiravir about $700 per course. Can you tell us is that right? And what are the natures of the discussions you have going on around pricing?

BOURLA: Look, I don't want to go into the details about ongoing discussions and negotiations but we are in very advanced discussions with the US government. We are in very advanced discussions I think with 90 governments, 9-0, right now about our oral. Obviously many of them were expecting to see how things will go in terms of the efficacy of the study if it's positive to start with and then the efficacy and I believe now is the catalyst that will advance all these discussions so by I think we will be having the news about the contracts pretty soon but we are in discussions with at least 9-0 countries.

TIRRELL: Wow. I also want to ask you about the drug safety profile because the fact that it doesn't have that mutagenic risk that is associated with Molnupiravir, Merck's drug, although Merck says the duration of the treatment makes it think they do not think that that is a risk for this indication. But your drug is co-formulated with Ritonavir, the, the HIV medicine that helps slow this sort of breakdown of your protease inhibitor in the body. Are there some drug, drug interactions to have to worry about there? What will the sort of safety profile of this medicine look like do you think?

BOURLA: Yeah, the amazing thing was that the safety profile about Merck 's was very impressive. In fact, it was way less adverse events in the treatment group than in the placebo group. If we go to the serious adverse events particularly, we had 1.7% in the treatment group and 6% in the placebo group which is explained because this is a serious disease so there's a lot of adverse events happening because of the disease.

ANDREW ROSS SORKIN: Albert, this, this may be a follow up to what Joe was, was discussing in terms of those who don't want to get vaccinated at all. But what kind of conversations you, have you had in Washington or with other, with other folks about what this may do to the conversation around boosters?

BOURLA: Boosters are needed. Boosters are needed because without them we will never get rid of this vicious cycle of the disease. We need to have people that are vaccinated and they have their immune system then, their antibodies at a very high level so that we can stop the replication of the virus. We need to have herd immunity otherwise that will continue forever. But for those that are either they didn't get vaccinated or they were unfortunate, I think this will be very good news because that will reduce deaths and hospitalizations significantly, dramatically.

KERNEN: Hey Albert. Obviously, HIV totally different. It's not, in terms of how long it lasts in the body and goes into a person's DNA but, but it did, it was able to get around the initial therapeutics through mutations. That's why we eventually in addition to a protease inhibitor, we added other mechanisms in the cocktail work much better. Does it, does COVID have the ability to get around, I guess we don't know at this point, but would you imagine that there you will need a regimen of therapeutics to totally stop COVID or in other words can mutate around your protease inhibitor?

BOURLA: The development of resistance it is possible but it is unlikely. It is unlikely first of all because this is a new class coming now with the 3CL protease. The second is that the 3CL protease which is what inhibits it is pivotal. It is essential for the function of the virus so it's very difficult to change that. And the third is most of the mutations are happening in the spike as you know. This one doesn't work with the spike, it works with the protease which is the 3CL which is part of the virus.

KERNEN: And how much, do you have any idea about how much this is going to cost?

BOURLA: You know, we are going to have the tier pricing again. We are going to be able to offer a very reasonable price with, comparable to what Merck is doing let me put it this way with the high income countries but we will have lower prices for middle-income countries and we are working on solutions on the low-income countries but we'll make sure that they will have ample access as well.

TIRRELL: And Albert, just going back to the question about potential viral evasion of the drug. Put more simply that suggests that it should work against all known variants, right?

BOURLA: Yes, because all the variants that we know so far are mutations in the spike. This has nothing to do with the way that this medicine works so it will work with all the medicine this is why also why I said that it's very unlikely to see mutation at least in the next few years. But if we do, of course we are monitoring that we will find solutions. As you know Meg, we've proven that we have the science to do it. You know, this one it was discovered from scratch. We started the program March 20th and within four months, I repeat not four years, four months, we have synthesized in vitro testing 600 molecules of protease inhibitor, 600. And then on July 20th, we've chosen this one. And then in 12 months, we were able to bring the results so it's, it's amazing, in 16 months actually, it is amazing how fast we were able to do it. Usually the discovery, the synthesis and the discovery lasts four years. We did it in four months.

TIRRELL: It is really remarkable Albert that you've been able to do this--

BOURLA: It is. I know.

TIRRELL: And now as you said, the, the results are so much better than you expected they were. Now you're ramping up the manufacturing. I'm wondering how you make decisions about how to allocate manufacturing space when you have a drug that could work so well for this pandemic bug. Are there any considerations about either switching out other drugs for this drug or ramping down some of your plans for the vaccine with this drug? I mean, it's a different manufacturing process but how do you process all those different decisions?

BOURLA: It's very different manufacturing process with a vaccine and the manufacturing of this one is happening in very different manufacturing sites that are working for the vaccines so vaccines will not be affected. Clearly, how we allocate manufacturing capacity, we are all hands-on deck. Everything goes this is the number one priority. This affects humans' lives. This is where we go first.

KERNEN: Hey Albert, we're obviously excited about this from the, the health aspects, the science aspects, everything else. I'm going to be very gauche now and bring up some of the proposed legislation with keep it goes in, it comes out, the drug pricing the far left really, really wants it included in some of these proposals that that are actually being voted on today. I know you employ lobbyists. I am sure that you believe that the innovation that comes from pharmaceuticals is the best deal in town when instead of chronic stays at hospitals, etc. But there's a lot of pressure. There's still a target on Big Pharma's back in terms of pricing and in terms of patents and everything else. But where do we think we are right now and what would you, what would your feeling be about what should be included in Build Back Better?

BOURLA: First of all, I think that the drug pricing in America is a serious problem. But the problem is that the Americans are paying for their medicines out of their pocket like if they don't have insurance although they have. The insurance should cover the cost of the medicines. And the cost of medicines to insurance represents 12% of the total healthcare costs. So, this is not the problem. And by the way, our prices went minus 5% this year and minus 2% last year so they are going down, they're not going up. The problem is that the Americans they don't see it minus 5 when they get one of our products. They see plus 20% plus 30% because it has nothing to do how much we charge versus how much they have to pay out of their pocket. That needs to be resolved. Now, that is the problem that needs to be resolved. What I think some parts of the Congress are trying to do it is just without reason punish the industry and, and reduce not the out of pocket which is very reasonable to be reduced but in general attack the industry. It is said because as you said if there is one lesson learned in this pandemic, it is the power of science and the power of a vibrant life sciences sector. This is what have saved trillions, right now, trillions of funds to the US and globally economy just because of the introduction of vaccines and now because of the introductions of the, of the antiviral treatments. So, I think it's wrong.

SORKIN: Albert, just philosophically and I know you're still negotiating and trying to figure out the pricing for this. I was just looking as you were speaking that Tamiflu costs without insurance somewhere between about $155 and $175. Now I don't know if that's a fair comparable to what this drug is going to do in terms of being able to save people in there and how many days they would have otherwise been potentially in the hospital or of course died and therefore how you do that valuation but just speak to that and how you think about it.

BOURLA: The way we think it is that this is a pandemic, so it makes sure that we're very reasonable with the prices. As I said likely we will price with Merck but that could give you magnitude of size. This is likely one-third, or I don't know, clearly more than one half of less than half of what the antibodies are costing right now. So, it's really very reasonable.

TIRRELL: And Albert so just going back to the Merck comparison, you've said it may be similar to that pricing around $700 per course. I'm wondering also just how you look at the, the marketplace for these two drugs hitting the market at the same time. Your data are different 89% for yours. I mean that's given within three days if you give it within 5, 76% reduction versus Merck's 50%. How do you compare these two drugs and how do you expect they'll get used?

BOURLA: Actually when you gave it in five days it was 85% reduction. 89% in the first three, 85% so it is very consistent the reduction of hospitalization and death, but I don't think it's fair to make comparisons right now with Merck. We didn't study the two drugs in the same study. I think the populations were similar and I think there is room for both. We know what we can speak it is that we have outstanding efficacy and outstanding safety profile and these are the data that we are going to present to the world.

TIRRELL: All right, Albert, thanks for joining us on such a historic morning and the almost anniversary of your vaccine data. November is a good time for Pfizer and for us with your drugs and vaccines.

BOURLA: I will say Meg November is a great time for the world and for humanity. We are speaking about a year ago November saved millions of lives. And we are expecting to see additional millions of lives being saved because of what we presented this November.

TIRRELL: Alright, thanks again. And Joe back to you.