Good day to all.
Good CC with Nader and the team last night.
We have filled for EUA. If the FDA is what it should be it, and does what it should do, would either approve us with a P4 or give us EUA. This is the right course of action in a country with much more than 1000 deaths per day and widespread economic suffering.
They unabashedly gave it to Remesivir, and India approved a drug for billions of people in basis of 3 patients. No exaggeration here.
But they might not (I have never trust them) and we will have to go for a quick P3 with the following characteristics:
For moderate-only patients (more than 4 points in ordinal scale, maybe higher)
75-85 patients
NEWS2 primary end point at 3 days.
3 and 7 days measurements.
Normally P3 are with much larger number of patients for a couple of reasons: safety (no need here as we know we are safe) and statistics (higher power).
As per NP we will go for a low number, however, we should be able to enroll very fast and have enrolling hospitals at-the-ready. I would do a 120-140 patients trial.
This should not be necessary, but we are not BP (I hope I am wrong).
In the same subject, our S-C (CD12) is very promising factoring in the results of the M-M. Is just mater of time. We will get our day in court.
We should pat ourselves in the back (I do it myself by acquiring more shares
) we successfully carried out a double-blinded trial for COVID. No small feat. We should be recompensed and will be.
FDA: There is an unmet clinical need out there. It s called COVID-19, in case you have not noticed. Thousands are dying daily and the economical structure of the world has gone to an screeching halt. There is a drug that has proven to help and is needed NOW not tomorrow when there will be several deaths (one every 18 seconds in USA alone, to be more specific).
Please do the right thing and, just this time, forget your deep-pocket sponsors, and do what you were stablished to do: approve SAFE and efficacious drugs needed by the public in a timely fashion.
Good CC with Nader and the team last night.
We have filled for EUA. If the FDA is what it should be it, and does what it should do, would either approve us with a P4 or give us EUA. This is the right course of action in a country with much more than 1000 deaths per day and widespread economic suffering.
They unabashedly gave it to Remesivir, and India approved a drug for billions of people in basis of 3 patients. No exaggeration here.
But they might not (I have never trust them) and we will have to go for a quick P3 with the following characteristics:
For moderate-only patients (more than 4 points in ordinal scale, maybe higher)
75-85 patients
NEWS2 primary end point at 3 days.
3 and 7 days measurements.
Normally P3 are with much larger number of patients for a couple of reasons: safety (no need here as we know we are safe) and statistics (higher power).
As per NP we will go for a low number, however, we should be able to enroll very fast and have enrolling hospitals at-the-ready. I would do a 120-140 patients trial.
This should not be necessary, but we are not BP (I hope I am wrong).
In the same subject, our S-C (CD12) is very promising factoring in the results of the M-M. Is just mater of time. We will get our day in court.
We should pat ourselves in the back (I do it myself by acquiring more shares
) we successfully carried out a double-blinded trial for COVID. No small feat. We should be recompensed and will be. FDA: There is an unmet clinical need out there. It s called COVID-19, in case you have not noticed. Thousands are dying daily and the economical structure of the world has gone to an screeching halt. There is a drug that has proven to help and is needed NOW not tomorrow when there will be several deaths (one every 18 seconds in USA alone, to be more specific).
Please do the right thing and, just this time, forget your deep-pocket sponsors, and do what you were stablished to do: approve SAFE and efficacious drugs needed by the public in a timely fashion.
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