MisterBlues schreef op 10 september 2020 11:06:
Aannemelijke verklaring over het tijdsschema van fase 2b/3 critical group
Some discussions on trial completion dates do not make sense to me. Here, it is my estimation again, especially for new investors here. If you saw this before, please just ignore it.
IMO, the whole P2/3 trial will be completed by this week (September 11) or even slightly earlier.
Key patient numbers at different time points to support my estimation.
1. June 1, 1st patient of the trial.
2. July 16, the DMSC stated the drug was safe by looking at the first 30 patients. They recommended that primary endpoint was changed to “alive and free of respiratory failure after 7-10 days” from mortality after 28 days. Please note the first 30 patients have went through 28 days before the DMSC could check the endpoint. This number is important for our estimation.
3. August 7, Dr. Javitt said that they had 75 patients in an interview. August 12, Dr. J said that they had 86/87 patients in the interview with Dr. Yo. It tells us that at least ~2 patients/day would enroll or complete the trial, i.e. 28 day monitoring.
Some argued the speed of patient enrollment. Is 2 patients/day reasonable through the trial? Let us check it.
On June 15, 30 patients enrolled (15 days x 2 patients/day). These are the first 30 patients who went through 28 day monitoring and were examined by the DMSC on July 16.
On August 7, they had 30+22 days x2 =74 patients (Dr. J said they had 75 that day)
On August 12, they had 30+27days x2 =84 patients (Dr. J said that they had 86 patients).
On August 21, they had 30 + 36 days x 2=102 patients (that is what needed for interim analysis).
On Sep 11, they would have 30+ 57days x2=144 patients (this will complete the trial).
Please note: all these patients at time points mentioned above have went through 28 day monitoring after treatment.
My estimation is slightly conservative. I used exactly 2 patients/day (it may be a little bit higher, especially later in the trial). Therefore, my estimation may be a few days behind the real situations. I also assume that equal time would be spent for analyzing data by the DMSC in July and NeuroRx at the end of trial.
I believe the interim data were positive and had been discussed with FDA. The trial is close to be completed if not yet by now. This is the reason why they updated the information in clinical trials website at the end of August by removing unnecessary sites, adding endpoints, but remaining sample size and completion dates.
They have been so silent. Connect the dots.
The FDA approval is coming!
Relax and wait!!