These are observations not calculated bashing, I have no interest in changing investor confidence, why would I that is every person's personal decision.
I infer data to 60 days is not available and thus the filing for a new trial of 140 patients.
Posters are correct 62/390 patients were critical, that is problematic.
A trial is conducted to test a hypothesis, the success in answering that question is trial design.
I mentioned in the fall all cause mortality creates difficulties in clinical trials, we see that now.
People have asked what could have been done differently, probably input from more clinicians and scientists in trial design, i.e chose resolution of respiratory failure as the endpoint.
Secondly, if you remember enrollment numbers were waning in the fall and I think that is when the imbalance of severe/critical enrollment occurred, this should have recognized even if meant waiting a month or two for data.
Proactively, I think there were enough signs in December to move to 60 days rather than waiting for the FDA February surprise.
IF the new trial is for 140 NEW patients, recruitment could be a challenge and if the 60 day endpoint is still requested it could take a while.
Hate me, just my humble observations.
I infer data to 60 days is not available and thus the filing for a new trial of 140 patients.
Posters are correct 62/390 patients were critical, that is problematic.
A trial is conducted to test a hypothesis, the success in answering that question is trial design.
I mentioned in the fall all cause mortality creates difficulties in clinical trials, we see that now.
People have asked what could have been done differently, probably input from more clinicians and scientists in trial design, i.e chose resolution of respiratory failure as the endpoint.
Secondly, if you remember enrollment numbers were waning in the fall and I think that is when the imbalance of severe/critical enrollment occurred, this should have recognized even if meant waiting a month or two for data.
Proactively, I think there were enough signs in December to move to 60 days rather than waiting for the FDA February surprise.
IF the new trial is for 140 NEW patients, recruitment could be a challenge and if the 60 day endpoint is still requested it could take a while.
Hate me, just my humble observations.
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