Our P2 Mild-Moderate (75) trial is very small in c
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Posted On: 06/04/2020 10:38:26 AM
Our P2 Mild-Moderate (75) trial is very small in comparison to those mentioned in that Seeking Alpha article, and many other COVID trials I've looked at.
And our P3 Severe-Critical (390) has a interim readout of only 50.
Makes me wonder two things:
1. Were these small trial/readout sizes a function of the fact that the FDA did not believe that leronlimab could play a role in addressing COVID? It has been mentioned several times now that leronlimab was initially discounted and sent to the back of the line because the FDA did not think it had applicability.
2. Even if our two trial results are good, and backstopped by Dr. BP's (anticipated) peer reviewed manuscript, and maybe supplemental EIND data -- is the FDA going to insist on larger confirmation trials that are similar in size to those of the competitors?
I have to imagine the FDA is still stinging from the scrutiny of recent missteps and wonder if they might feel that they can't approve a drug based on trial sizes that are so much smaller than competitors.
That would be both disappointing and infuriating.
And our P3 Severe-Critical (390) has a interim readout of only 50.
Makes me wonder two things:
1. Were these small trial/readout sizes a function of the fact that the FDA did not believe that leronlimab could play a role in addressing COVID? It has been mentioned several times now that leronlimab was initially discounted and sent to the back of the line because the FDA did not think it had applicability.
2. Even if our two trial results are good, and backstopped by Dr. BP's (anticipated) peer reviewed manuscript, and maybe supplemental EIND data -- is the FDA going to insist on larger confirmation trials that are similar in size to those of the competitors?
I have to imagine the FDA is still stinging from the scrutiny of recent missteps and wonder if they might feel that they can't approve a drug based on trial sizes that are so much smaller than competitors.
That would be both disappointing and infuriating.
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