Quote:I was wondering about the possibility of the DSMB triggering an early mCRC trial stoppage for overwhelming Leronlimab efficacy. IF we're lucky enough for it to eventually happen (and it admittedly might be a longshot, however I do think it's possible given the impressive publicly revealed open-label trial data so far), here's how it works and how it could benefit CYDY shareholders and patients:
Highly unlikely. With a partial trial and a low number of patients who have completed it the DMSB would realize the huge confidence intervals and lower p values that would make it almost impossible to get an approval. Once the trial is stopped you then are screwed on getting an approval on full trial data. Even if the DMSB wants to stop it Dr. Lalezari has enough experience to refuse to do it. If the FDA allowed data from patients that haven't finished the trial then the only thing you have to hang your hat on is the objective response rate. That would be skewed b patients who are early in the trial and haven't yet had a substantive response. Duration of response. progression free survival and overall survival go straight out the window. With the shorter time frame for patients who have not completed the trial there may be little difference to standard of care because at the same point in time in other companies trials worsening conditions may not have occurred yet.
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