Regarding this excellent interview on Al Jazeera of Dr. NP which was posted just yesterday:
Video Link: https://www.youtube.com/watch?v=iBHRTf9Q7eA
There are a couple of "big ticket" topics that I have not heard anyone raise:
Video Link = https://youtu.be/iBHRTf9Q7eA?t=156
1. Other than CytoDyn's (assumed) failed attempt to gain FDA approval based upon the relatively small, non-control, EIND program, I don't remember any previous statement by Dr. NP regarding asking the FDA for approval of the drug for compassionate use.
Does anyone else remember this?
Is this a preview of what might be discussed on Monday?
2. At the very end of the Friday, April 17 conference call, while discussing his research paper, Dr. BP indicated that all of the data would finally be available in one week (that was yesterday), and that the paper would be submitted in two weeks (next Friday), and that it would not be published for 4-6 weeks (between May 8 and May 21). And, I noted in a post around that time that the release of paper would coincide nicely with the read-out of 2-week preliminary results. In this Al Jazeera interview, Dr. NP is stating: "... we will be publishing a paper hopefully by the end of this week."
My Comments:
Am I assigning too much significance to this remark?
Does anyone think the paper will be publicly circulated prior to being officially published between May 8 and May 21, according to Dr. BP?
3. Video Link: https://youtu.be/iBHRTf9Q7eA?t=188
I have no idea what to make of Dr. NP's response. Can anyone interpret this for me -- in a clear and concise manner that allows me to understand/predict if we may hear that the UK has approved emergency use of leronlimab, as was discussed in that same April 17th conference call?
4. Video Link: https://youtu.be/iBHRTf9Q7eA?t=326
Video Link: https://www.youtube.com/watch?v=iBHRTf9Q7eA
There are a couple of "big ticket" topics that I have not heard anyone raise:
Video Link = https://youtu.be/iBHRTf9Q7eA?t=156
My Comments:Quote:"We are now close to asking the FDA to approve the drug for compassionate use for everybody who is in severe condition because our mechanism of action which will be publishing a paper hopefully by the end of this week or so"
1. Other than CytoDyn's (assumed) failed attempt to gain FDA approval based upon the relatively small, non-control, EIND program, I don't remember any previous statement by Dr. NP regarding asking the FDA for approval of the drug for compassionate use.
Does anyone else remember this?
Is this a preview of what might be discussed on Monday?
2. At the very end of the Friday, April 17 conference call, while discussing his research paper, Dr. BP indicated that all of the data would finally be available in one week (that was yesterday), and that the paper would be submitted in two weeks (next Friday), and that it would not be published for 4-6 weeks (between May 8 and May 21). And, I noted in a post around that time that the release of paper would coincide nicely with the read-out of 2-week preliminary results. In this Al Jazeera interview, Dr. NP is stating: "... we will be publishing a paper hopefully by the end of this week."
My Comments:
Am I assigning too much significance to this remark?
Does anyone think the paper will be publicly circulated prior to being officially published between May 8 and May 21, according to Dr. BP?
3. Video Link: https://youtu.be/iBHRTf9Q7eA?t=188
My Comments:Quote:Correspondent: “So if the FDA gives you final approval would that also apply to other countries would it be good enough for the European Union or other countries to go ahead and start using the medication?
Dr. NP: “So each country has their own rules and regulation. United Kingdom has asked us already for the product to be involved in this test that we have they have indicated that the European Food and Drug Administration is agreeing to allow this product to be used in any clinical trial as long as the FDA in United States agrees to allow the clinical trials to go forward and have a green light. We have green light not for Phase 2 but also for one Phase 3 the final pivotal trial we believe and the other countries also always they follow the guidelines of FDA United States and the European Food and Drug Administration. So if both of these are aligned then the rest of the world would also immediately would allow us to be used for this special problem."
I have no idea what to make of Dr. NP's response. Can anyone interpret this for me -- in a clear and concise manner that allows me to understand/predict if we may hear that the UK has approved emergency use of leronlimab, as was discussed in that same April 17th conference call?
4. Video Link: https://youtu.be/iBHRTf9Q7eA?t=326
Quote:In United States we have Bill Gates Foundation, NIH National Institute of Health Foundation reserve fundings we haveMy Comments:Quote:amfAR that has funding, Barda has funding -- so all these funds that could be used to disperse this product without any cost to the third-world countries is going to be at work immediately. I have been approached already by a couple those institutions and they are saying that your science look very strong, your results look strong, if we if it happens that you get approval which could happen in the next perhaps six to eight weeks even, if those best-case scenario happen can we be involved to immediately have this product available for third world country? And we said absolutely yes. They asked us for the cost of the product. The cost is very minimum it's not very large and it's we are able to cover the whole world. We have our manufacturing at Samsung biologic in South Korea said where they could produce tremendous amount of product. And we have manufacturing United States ready to go. Everything set we need the FDA approval and we needed to have some proof of concept. Things are going very well with the patients who have received this product in Emergency IMD and reported it. But the trial is double-blinded we don't know the results for another two or three weeks and then we will know what path we have to take.
I like that Dr. NP has stated he has "been approached already by a couple those institutions". I think we had all hoped/assumed that had taken place (due to the strength of the drug's efficacy) -- but now we have clear evidence.
I also like his comment "The cost is very minimum it's not very large and it's we are able to cover the whole world." I like that he is going on record as being able to scale production and distribution (my words) to the entire world.
Regarding pricing, we all know the cost issue is a double edged sword. In the context of a pandemic , the company's reputation would be permanently damaged if CytoDyn pulled a "Martin Shkreli" and price-gouged the entire world.
This is an incredibly important inflection point for the company, and it must exit this pandemic looking like the hero that saved the world -- and that saved the world like the other big pharma companies promised to do -- effectively for free.
However, when this is over, and CytoDyn moves forward to monetize leronlimab for other indications, I anticipate some blow-back regarding pricing. I can see the headlines: "Company that saved the world is now overcharging for their drug."
I also anticipate an overhang in inventory, with potentially millions of unused vials sitting all over the planet -- at the point that a vaccine is available.
Whether or not those vials will have expired (as suggested by another board member), whether or not an expired vial still has any effectiveness, and whether or not doctors around the world will inject their patients suffering from other diseases with those vials -- all remains to be seen.
However, we have to assume that by the time a vaccine is ready, and those vials are no longer necessary, we will have had FDA approval for Combo HIV, and maybe even a label extension for Mono HIV. And who knows how much progress will have been made, or how many BTD's we might have acquired, for other cancer and immuno indications.
In other words, the temptation to use those vials, in both 1st world and especially in 3rd world countries, might be very strong. And that glut of inventory will certainly have an impact on demand and revenue.
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