I initially thought so too, but I'm guessing it comes down to three variables:Quote:I'm guessing that we will have somewhere around 75 in the severe trial interim analysis.
1. When exactly the results of the P2 M/M are clear enough for CytoDyn to request FDA approval of an interim look at the P3 S/C
2. How long it takes for the P3 S/C data to be processed such that it can be presented to the FDA
3. And, finally, whether or not the results from both studies are actually going to be presented to the FDA at the same time
Worst Case Scenario: We might only have 65 to 69 in the interim P3 S/C
My math:
During the 6-11-2020 CC, Dr.NP stated that 69 patients were enrolled as of that day.
Since the P2 M/M may possibly read out ~2 weeks from July 1 (the day the 86th patient finished their 14-days), that maybe puts the read out sometime around July 15.
If the P2 M/M shows favorable results sometime around July 15, we are assuming that the company will ask the FDA to allow for an interim analysis of the P3 S/C trial.
With the largely binary primary endpoint of the P3 S/C trial (Day 28 Mortality, although we know there's also blood work), maybe it will take less time to process the data in that trial (but of course, I don't know).
If that data can be processed in just one week (unknown), and if CytoDyn intends to present the FDA with the results of both studies at the same time, then the last P3 S/C patient to be included in the interim look will need to have finished their 28 days a week earlier on July 8.
And, it stands to reason that the last patient who finished on July 8 must have then been injected no later than June 10 (28 days before).
And June 10 is the day before Dr.NP said we had 69 enrolled.
So, with all of those assumptions, I'm guessing we have 65-69 in that interim look.
Of course, this calculus all changes if:
1. The P2 M/M and P3 S/C results are not reported at the same time
2. The P2 M/M takes more time to process (or is intentionally slow walked) such that CytoDyn does not ask permission for an interim look at the P3 S/C until a week or two later than the scenario described above.
In either of those instances, and assuming the P3 S/C still needs to be reported to the FDA during the month of July -- you could conceivably be adding a week or two to the capture duration of the P3 S/C interim look.
And I think that's where you could easily hit 75+ patients.
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