I have listened to the call multiple times. Wha
Post# of 154056
(Total Views: 595)
Posted On: 05/27/2020 12:37:39 AM
I have listened to the call multiple times.
What NP effectively said was that it was going to take 2 weeks from today for the last P2 patient's data to be collected anyway. So, in two weeks they are going to assess how far short they are on full enrollment (75). If they are not far away, they will likely stay the course to achieve full enrollment -- because it does make a difference in terms of approval. Conversely, if they are still far away from 75, all parties (internal and external) will discuss the pros and cons of unblinding the trial.
Interestingly, and I believe this is the first time I have heard this from him, he indicated that preliminary results from the P2-3 can provided to the FDA at 50% of enrollment -- not 50 patients as I formerly understood. 50% is 195 patients (390 divided by 2). He then said that after receiving approval for the P2 they would ask the FDA to present interim results from the P2-3 (ostensibly before 195 had been enrolled).
I had been operating under the assumption that preliminary results from the P2-3 could be shared with the FDA based on the first 50 patients. And I think many others on the board believed the same to be true. And yet, no matter how many times I read the trial protocol, I could never find that specification.
It now makes more sense that the metric is 50% and not 50 patients, as I can imagine that might be a standardized approach across a plurality of trials. And I now understand that P2 approval is going to be the driver for providing the FDA with preliminary results from P2-3 before that 50% enrollment number is achieved.
What NP effectively said was that it was going to take 2 weeks from today for the last P2 patient's data to be collected anyway. So, in two weeks they are going to assess how far short they are on full enrollment (75). If they are not far away, they will likely stay the course to achieve full enrollment -- because it does make a difference in terms of approval. Conversely, if they are still far away from 75, all parties (internal and external) will discuss the pros and cons of unblinding the trial.
Interestingly, and I believe this is the first time I have heard this from him, he indicated that preliminary results from the P2-3 can provided to the FDA at 50% of enrollment -- not 50 patients as I formerly understood. 50% is 195 patients (390 divided by 2). He then said that after receiving approval for the P2 they would ask the FDA to present interim results from the P2-3 (ostensibly before 195 had been enrolled).
I had been operating under the assumption that preliminary results from the P2-3 could be shared with the FDA based on the first 50 patients. And I think many others on the board believed the same to be true. And yet, no matter how many times I read the trial protocol, I could never find that specification.
It now makes more sense that the metric is 50% and not 50 patients, as I can imagine that might be a standardized approach across a plurality of trials. And I now understand that P2 approval is going to be the driver for providing the FDA with preliminary results from P2-3 before that 50% enrollment number is achieved.
(1)
(1)