I don't disagree with this opinion.Quote:If anyone is 100% convinced that our trial data will be awesome, have you been paying attention for the last 4 years?
In spite of growing pandemic conditions, and the need for the current Administration to present a solution that might ensure reelection, I think there is a good chance the FDA demands a larger P3 of the M/M, and that the DSMC, at the very least, suggests that the P3 S/C be completed to at least 50% (195 patients) of the protocol.
On one hand, one only need look at the totality of events over the past 6 months (including today's) to conclude that the FDA has motivation to drive delays in our approvals. For example, what they have done with Combo HIV is shameless and unconscionable.
On the other hand, according to Dr.NP, Samsung can only deliver 30k vials in July. For those playing along at home, that number of vials can only treat 7,500 patients (assuming only 2 doses per patient, and not the 3 or 4 doses that some severe or critical patients might require, as discussed today).
Let's take a brief trip down memory lane:
Over the past 5 or 6 months, we have witnessed dramatic shifts in estimated production and inventory for 2020.
In the James West Letter Interview on April 28, Dr.NP claimed that AGC would hopefully begin delivering 600-700k vials beginning in June/July, and Samsung might be able to produce 5M vials by August/September.
Over the next couple of months, this Samsung production number subsequently morphed to 1.2M vials with the possibility of 2-3M additional vials by the end of the year.
Then, in the Dr. Been interview from last week, Dr.NP claimed that Samsung is now "booked" and that there will be a grand total of 1.1M vials this year, with a staggered delivery as follows: 30k vials by the end of July, followed by 200-300k vials per month starting at the end of August or early September.
Somehow, there's has been no further mention of AGC production. It has completely fallen off the grid and no one has had the forethought to ask about it in many calls over the past month or two.
Now, maybe those AGC 600-700k vials are being allocated to the White House and Administration (including members of both Houses and their families), Diplomats, CIA, NSA, FBI, Defense Department Brass, Military, Police, and Hospital Workers.
Alternatively, maybe those vials are earmarked for the dozens or hundreds of COVID (and other) trials that might take place in other countries after US COVID approval.
Or, lastly, maybe those vials are allocated for CytoDyn's own 10+ clinical trials anticipated to start by the end of the year. After all, AGC is the company that produced all of the product used in clinical trials to-date. Although I can hardly imagine CytoDyn would need 600-700k vials to support 10+ trials.
What is interesting is that in last week's Dr.Been interview, Dr.NP emphatically claimed that he told his Chief Technology Officer to order whatever Samsung can make.
- Video Link Excerpt: https://youtu.be/WiyjIIpkIJw?t=1888
Then, just days later in the Wall Street Reporter presentation, Dr.NP said that they haven't told Samsung to increase any more capacity yet because they are waiting for the results of the primary endpoint, and he inferred that the only additional capacity would be possible for 2021.
- Video Link Excerpt: https://youtu.be/SGLKa2Xi1gk?t=3062
Anyway, my point is that the FDA / Administration can hardly do their victory dance in front of the public claiming that THEY solved the pandemic, and at the same time announce that there are only enough vials to treat 7,500 sick people over the next month. Are they going to have a lottery to decide who lives and who dies -- and will there be widespread social unrest instigated by the families of dying patients?
For that reason alone, the FDA / Administration might intentionally impose a 1 month delay in CytoDyn's trial outcomes so that they can at least say to the general public (1 month later) that they have enough inventory to treat 57,500 patients (30k + 200k vials) with more on the way every month.
It would be easy for the FDA to explain this delay to the general public as being a necessary requirement to make sure leronlimab is safe and efficacious, even if they already had sufficient evidence to support those claims. And, that approach has the added bonus of allowing Gilead (and maybe Regeneron) to continue making outrageous and unsupported claims, and it gives them more time to sell product. It's a win-win.
Lastly, I really hope that the competitive 3-Arm remdesivir- leronlimab trial discussed back in May is somehow resurrected -- as I want Gilead to be publicly humiliated.
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