Although I am quite certain we could extend this d
Post# of 153937
(Total Views: 1048)
Posted On: 07/21/2020 6:17:36 PM
Although I am quite certain we could extend this discussion about the (very real) shortcomings of the PRs for another day or so, I'm now focused on how the next couple of weeks might play out.
Regarding timing, I have to assume that the M/M trial results (when they are completed) are a material event and therefore subject to immediate disclosure. I hope we learn more about the ETA of those results tomorrow, although it's probably better if the company does not predict a date.
I have a recollection that CytoDyn had aspirations of simultaneously presenting both trial results to the FDA in order to make the case that the sum is greater than the parts, in terms of gaining approval.
If that's still true, I'm guessing they'll sit on the M/M results (after public disclosure) until the outcome of the DSMC investigation is known.
The DSMC can decide to:
1. Terminate due to futility
2. Proceed to interim 50% (195)
3. Terminate due to overwhelming benefit
If we are lucky enough to get Number 3, the data processing will take some time even though the primary endpoint is binary (Death at Day 28). Remember, there are other secondaries and Dr.BP's assays that need to be processed and packaged.
So, if we get Number 3, and the goal is to still present both results to the FDA at the same time, I don't see that happening until the first or second week of August. And then the FDA needs an unknown (by me) amount of time to render a decision.
Now, regarding uplisting, based on the last CC, the company projected the SEC 10k and audited financials would be completed sometime between August 7-14, and that NASDAQ would want some time to review them (which I estimate as being around one week or so).
My take away from all of this is that the uplist might very well occur before the FDA rules on the trials. Interestingly, I had been operating under the assumption that it would be the other way around, and was quietly annoyed that the stock price would not benefit from a broader investor base on the day of (a hopeful) FDA approval.
Other Considerations:
1. I don't know if the company considers uplisting as being conditional on getting at least one COVID approval. If so, I could see the NASDAQ process being pushed back until the FDA rules.
2. If the FDA demands a Phase 3 M/M, all bets are off in terms of the discussion above.
3. If the DSMC advises to continue the S/C trial to interim 50%, then once again, all bets are off in terms of the discussion above. As a side note, if we had ~152 enrolled as of last Saturday, we're possibly looking at 'best case' 6+ weeks to complete the 195th patient.
Regarding timing, I have to assume that the M/M trial results (when they are completed) are a material event and therefore subject to immediate disclosure. I hope we learn more about the ETA of those results tomorrow, although it's probably better if the company does not predict a date.
I have a recollection that CytoDyn had aspirations of simultaneously presenting both trial results to the FDA in order to make the case that the sum is greater than the parts, in terms of gaining approval.
If that's still true, I'm guessing they'll sit on the M/M results (after public disclosure) until the outcome of the DSMC investigation is known.
The DSMC can decide to:
1. Terminate due to futility
2. Proceed to interim 50% (195)
3. Terminate due to overwhelming benefit
If we are lucky enough to get Number 3, the data processing will take some time even though the primary endpoint is binary (Death at Day 28). Remember, there are other secondaries and Dr.BP's assays that need to be processed and packaged.
So, if we get Number 3, and the goal is to still present both results to the FDA at the same time, I don't see that happening until the first or second week of August. And then the FDA needs an unknown (by me) amount of time to render a decision.
Now, regarding uplisting, based on the last CC, the company projected the SEC 10k and audited financials would be completed sometime between August 7-14, and that NASDAQ would want some time to review them (which I estimate as being around one week or so).
My take away from all of this is that the uplist might very well occur before the FDA rules on the trials. Interestingly, I had been operating under the assumption that it would be the other way around, and was quietly annoyed that the stock price would not benefit from a broader investor base on the day of (a hopeful) FDA approval.
Other Considerations:
1. I don't know if the company considers uplisting as being conditional on getting at least one COVID approval. If so, I could see the NASDAQ process being pushed back until the FDA rules.
2. If the FDA demands a Phase 3 M/M, all bets are off in terms of the discussion above.
3. If the DSMC advises to continue the S/C trial to interim 50%, then once again, all bets are off in terms of the discussion above. As a side note, if we had ~152 enrolled as of last Saturday, we're possibly looking at 'best case' 6+ weeks to complete the 195th patient.
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