99.95% of the BLA is the clinical section. TENS of THOUSANDS of pages. here's the good news... all the of the scrambling around for "shortcuts" is irrelevant. if the company can PROVE the value of the drug in MSS-CRC, then everything takes care of itself. timelines to approvals aren't even worth discussing. i only do that because there is a shareholder contingent that is demented and i am not a fan of dementia.
The MSS-CRC trial is all that matters. NOTHING else matters. yes there are other things that can become very important, but they really don;t matter at all, good or bad, as long as the MSS-CRC trial shows tumor shrinkage through 8 and 12 week scans, and the PD-1 expression is 4x higher or whatever. any other talk regarding any other indications, good or bad, isn't even relevent. you could make a case for tnbc, sure, but even that really doesn;t matter as long as MSS-CRC succeeds, and only matters slightly because they could have some compassionate use success.
timelines (my favorite), pipelines, org charts, bread crumbs, mgk's (and whatever his name is here) aimless ramblings across 5 years with a combined total of 5000 incorrect predictions, NONE of that really matters.
competitive environment matters, but for now cytodyn has a moat with MSS-CRC and the lead position with hot-to-cold.
funding matters, and that is a little bit sketchy, but MSS-CRC data is coming well before the latest trough runs dry.
my expectation on an MSS-CRC data release is april or may. guessing 30 enrolled end of january, 8 week scans on 30 by end of march. would be better to share after having 12 week scans end of april, so that ORR on 30 patients (20 at 350 and 10 at 700) is known.
meanwhile that is based on me guessing at the pace of enrollment and guessing at whether they started dosing 700mg after 20 patients and guessing when they are doing scans and guessing what they might be thinking is a good cutoff for sharing data.
i would actual prefer they wait until 20/20 350/700mg. and at 12 weeks (assuming scans at 8 and 12) they would have an ideal amount of PD-1 and tumor shrinkage and ORR data. my hope i they wait until may, but my guess is they will share in april. but who knows? it could come any time, based upon how strong the data is. the stronger the data the earlier they choose to share imo.
The MSS-CRC trial is all that matters. NOTHING else matters. yes there are other things that can become very important, but they really don;t matter at all, good or bad, as long as the MSS-CRC trial shows tumor shrinkage through 8 and 12 week scans, and the PD-1 expression is 4x higher or whatever. any other talk regarding any other indications, good or bad, isn't even relevent. you could make a case for tnbc, sure, but even that really doesn;t matter as long as MSS-CRC succeeds, and only matters slightly because they could have some compassionate use success.
timelines (my favorite), pipelines, org charts, bread crumbs, mgk's (and whatever his name is here) aimless ramblings across 5 years with a combined total of 5000 incorrect predictions, NONE of that really matters.
competitive environment matters, but for now cytodyn has a moat with MSS-CRC and the lead position with hot-to-cold.
funding matters, and that is a little bit sketchy, but MSS-CRC data is coming well before the latest trough runs dry.
my expectation on an MSS-CRC data release is april or may. guessing 30 enrolled end of january, 8 week scans on 30 by end of march. would be better to share after having 12 week scans end of april, so that ORR on 30 patients (20 at 350 and 10 at 700) is known.
meanwhile that is based on me guessing at the pace of enrollment and guessing at whether they started dosing 700mg after 20 patients and guessing when they are doing scans and guessing what they might be thinking is a good cutoff for sharing data.
i would actual prefer they wait until 20/20 350/700mg. and at 12 weeks (assuming scans at 8 and 12) they would have an ideal amount of PD-1 and tumor shrinkage and ORR data. my hope i they wait until may, but my guess is they will share in april. but who knows? it could come any time, based upon how strong the data is. the stronger the data the earlier they choose to share imo.
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