Let's quickly model the probability of achieving a halted trial by the end of the year that provides enough time for a double digit capital raise and a subsequent payment to Samsung.Quote:IMO, it appears NP is trying to get the interim analysis completed and returned by the end of the year, before the large payment is due to Samsung. His hope is that the trial will be halted at that time and will increase the SP, so funds can be raised and uplsiting can take place. I believe it’s likely we’ll see a few small raises in the near future to cover short term costs but only a large raise if enrollment is still slow. I think it’s a fair strategy by NP but he has to put serious funds and efforts towards enrolling in order to overcome competition from BP.
This is a very optimistic list, there will likely be all manner of slippage in each of these categories and there is no time budgeted for FDA discussions. But here are the broad strokes assembled in descending order:
- December 31, 2020 -- Money owed to Samsung
- December 23, 2020 -- Stock sold/cleared -- or Plan B initiated (Debt Instrument?)
- December 16, 2020 -- Underwriter initiates stock offering
- December 15, 2020 -- CytoDyn halts trial based on DSMC recommendation
- December 08, 2020 -- DSMC receives/analyzes unblinded data for one week
- November 24, 2020 -- Two weeks are budgeted to lock and process data
- November 24, 2020 -- 293rd Patient completes 42 days (or perishes/drops-out)
- October 13, 2020 -- 293rd Patient is enrolled in CD12 (that was a week ago)
So, as you can see, it is physically impossible to complete the interim analysis in calendar 2020, such that a double digit capital raise can happen afterward, allowing for a payment to Samsung.
But let me take this model one step further. Let's assume for a moment that Dr.NP hits the lottery and doesn't need a double digit capital raise to pay Samsung. So let's eliminate the following line items from this timeline:
- Underwriter initiates stock offering
- Stock sold/cleared -- or Plan B initiated (Debt Instrument?)
- Money owed to Samsung
In doing so, we will have saved a total of 15 days, which would then require that we achieve enrollment of 293 patients in the CD12 by October 28. That's 63 patients -- one week from now. Not going to happen.
It is my belief that we will need to raise money to pay Samsung in a different manner.
And once we remove the necessity of a trial halt and double digit capital raise in calendar 2020, we are left with this more likely scenario (albeit still very optimistic) in ascending order:
- October 21, 2020 -- Enrollment is fast tracked to an average of 2 patients per day
- November 22, 2020 -- 293rd Patient is enrolled in CD12
- January 03, 2021 -- 293rd Patient completes 42 days (or perishes/drops-out)
- January 03, 2021 -- Two weeks are budgeted to lock and process data
- January 17, 2021 -- DSMC receives/analyzes unblinded data for one week
- January 24, 2021 -- CytoDyn halts trial based on DSMC recommendation
Remember, this is still a very optimistic timeline. We likely will not enroll 63 patients in 4 weeks, there will be all manner of slippage in other categories, and there is not time budgeted for FDA discussions.
This is the reason I drafted my question to Dr.NP -- to get confirmation that the next interim analysis would occur around February 2021. And as you all heard, he rejected my assertion.
It took me all of 15 minutes to create this post. And if I haven't made a gross error in my calculations, I consider this to be a problem.
Telling tens of thousands of investors on a conference call that the interim analysis will be done in December 2020 is a serious mistake for many reasons, not the least of which is the shareholder blowback when it doesn't happen. This is another completely avoidable, self-inflicted error -- and it unfortunately leads to an erosion of confidence. Yes, incremental progress is being made by members of the management team -- but we're still not there yet. Sorry CDiddy.
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