blafarm,
Appreciate your detailed analysis.
I too was frustrated at first by the apparent shift in strategy from interim analysis being done on the first 51 patients in the s/c trial. Having heard that repeated more than once I shared it with other potential new investors as the company's covid strategy and ended up with lots of people questioning me after it came out that we were no longer doing that..."I thought you said..."
As I have had time to think about it however, I am beginning think this may be a strategic attempt to have a Plan B ready to go should Plan A not produce the results we want with the FDA, namely approval of some kind.
Plan A - Ask for approval assuming 87 m-to-m patients show outstanding results
If FDA responds to solid m-to-m results by asking for Phase 3 go to Plan B
Plan B - Strategically pick a number of patients in s/c trial that would result in a quick 28 day turn around AND statistically significance to do an interim analysis of
When you think about it, it makes sense as a one-two punch. If we had gone with our original plan we could have been told phase 3 for m-to-m and finish out the full s/c trial. Then, we are in a tricky spot. But given the amazing work Dr. Recknor did at ramping up our m-to-m enrollment at the last minute, we can now have a second move to play should our first move not produce the result we want. I think it makes the FDA look worse if we have two solid sets of data showing statistically significant results in controlled trials and the FDA tells us again to do more (at that point, we have probably done all we could to get early approval anyhow).
This might also explain why we haven't heard how many patients will be in the s/c interim analysis. Given that they don't know how long it will take for the FDA to respond, they may want to see what happens with the m-to-m and then make the call when they get the FDA response. At which point CytoDyn could look at the 28 day dates for all the patients in the s/c and figure out how to balance statistical significance with being able to quickly ask for interim analysis. This is in contrast to my initial reaction of "ugh, this will now go out to August"
And just to confirm, Dr. BP in the Dr. Yo video did describe a marker they use in leronlimab that they can measure to show CCR5 occupancy. I think that is why they keep dancing around the question of who is on leronlimab vs. the placebo. They don't technically 100% "know" as it is blinded but they "know" because of the CCR5 occupancy test. The only thing we don't know for certain is whether they are doing this test for everyone. Dr. BP in his TEDx talk did emphasize "hundreds and hundreds" of samples so I am hopeful they are being done for all the trial patients.
Hope everyone has a Happy 4th!
Appreciate your detailed analysis.
I too was frustrated at first by the apparent shift in strategy from interim analysis being done on the first 51 patients in the s/c trial. Having heard that repeated more than once I shared it with other potential new investors as the company's covid strategy and ended up with lots of people questioning me after it came out that we were no longer doing that..."I thought you said..."
As I have had time to think about it however, I am beginning think this may be a strategic attempt to have a Plan B ready to go should Plan A not produce the results we want with the FDA, namely approval of some kind.
Plan A - Ask for approval assuming 87 m-to-m patients show outstanding results
If FDA responds to solid m-to-m results by asking for Phase 3 go to Plan B
Plan B - Strategically pick a number of patients in s/c trial that would result in a quick 28 day turn around AND statistically significance to do an interim analysis of
When you think about it, it makes sense as a one-two punch. If we had gone with our original plan we could have been told phase 3 for m-to-m and finish out the full s/c trial. Then, we are in a tricky spot. But given the amazing work Dr. Recknor did at ramping up our m-to-m enrollment at the last minute, we can now have a second move to play should our first move not produce the result we want. I think it makes the FDA look worse if we have two solid sets of data showing statistically significant results in controlled trials and the FDA tells us again to do more (at that point, we have probably done all we could to get early approval anyhow).
This might also explain why we haven't heard how many patients will be in the s/c interim analysis. Given that they don't know how long it will take for the FDA to respond, they may want to see what happens with the m-to-m and then make the call when they get the FDA response. At which point CytoDyn could look at the 28 day dates for all the patients in the s/c and figure out how to balance statistical significance with being able to quickly ask for interim analysis. This is in contrast to my initial reaction of "ugh, this will now go out to August"
And just to confirm, Dr. BP in the Dr. Yo video did describe a marker they use in leronlimab that they can measure to show CCR5 occupancy. I think that is why they keep dancing around the question of who is on leronlimab vs. the placebo. They don't technically 100% "know" as it is blinded but they "know" because of the CCR5 occupancy test. The only thing we don't know for certain is whether they are doing this test for everyone. Dr. BP in his TEDx talk did emphasize "hundreds and hundreds" of samples so I am hopeful they are being done for all the trial patients.
Hope everyone has a Happy 4th!
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