Some food for thought.
Out trial is adaptive. There is
Some food for thought.
Out trial is adaptive. There is the possibility that the DSMC will make recommendations on trial modifications including end-points as well.
We should remember that the DSCM “works” for CYDY. In a way, they will advise us on the best path forward, provided of course, that Leronlimab is showing some sizable therapeutic benefit.
Several things can happen in regards of DSCM report:
Continue the trial (meaning we are in a good path to approval, that is, statistical significance can be achieved once full enrollment is achieved).
Modify the trial as far as quantitative outcomes. i.e. increase the number of patients.
Modify the trial as far as cohorts: i.e. separate critical for moderate and re-design the criteria for enrollment and associated patient numbers.
Modify/change the primary end-point: As COVID is a “moving target” and we were really bold on going for mortality at 28 days (we have to give it to ourselves, not many companies have the “cojones” to go for mortality). Care is changing day after day and mortality is a VERY difficult point to “probe” as external circumstances (as improved care, therapies, experience) will be affecting the results as time goes by. One can hope that this affects the SOC and LL arms equally.
Stop the trial for efficacy. For this the FDA will need to be consulted as this will obviously affect the trial in general and the possible outcome (approval sought by the company). If the results were reported to CYDY (AMAREX) last week we would be In talks with FDA regarding next steps.
DSCM reports very good results and CYDY decides to try and get an EUA. This will need to be consulted with FDA as well before the trial is stopped (if this is what is decided).
So, we are in for a very interesting CC tomorrow. We will know whatever the potential regulatory path forward is.
Looking forward to it.
10
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