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Posted On: 04/15/2020 1:35:01 PM
Post# of 148878
Re: Shelly2626 #27788
“What goes down ...will even go up more ...we are only a couple weeks away at this point ....”
I think we need to have a discussion on realistic timelines in regards to approval for COVID. At this point, a couple of weeks seems unlikely given a number of factors:
1. Trial enrollment speed - Trial enrollment has been slow over the past two weeks because of the administrative process required at each hospital. I expect both of the COVID trials to increase in terms of speed, but I still don’t see the 75 patient phase 2 for mild/moderate fully enrolling for another 2 weeks or so (I believe NP set a similar timeline in a recent video). CYDY is a small biotech competing for trial patients with other BPs. I don’t expect the severe trial to fill any quicker unless the main hospital(s) participating in the trials are in NY or CA and involve doctors who have participated in the EIND. You’d think with hundreds still dying each day in NY, CYDY could fill the trial in a couple of days, but again, I think the administrative side of the trial and CYDY’s small size and limited cash prevents this from happening.
2. Trial protocols
The primary endpoint for the mild/moderate trial is clinical improvement at 2 weeks with a multitude of secondary endpoints at 2 weeks as well, including incidence of hospitalization, duration of hospitalization, and the same for ventilation. Once the last of the 75 patients is enrolled, a two week clock starts until data from all 75 patients is collected. Add another week or so for the data to be analyzed and prepared for submission to the FDA. So let’s say 3 weeks from enrollment of the 75th patient. This trial, as of today, has 15 patients enrolled in it after the first two patients were enrolled on April 6th. Hopefully, like I said above, this trial will completely enroll in 2 weeks as more centers are added. If it does, we’re looking at mid-May or June for full data.
The severe trials primary endpoint is mortality at 28 days and the secondary endpoint is 14 days. For that trial we’ll need at least 1 month of data from 50 patients before interim analysis. If those 50 patients are fully enrolled 2 weeks from now, CYDY could have interim results in late May or early June, depending on the time needed to analyze it. The question here, as outlined above, is how quickly can those 50 patients get enrolled.
3. EIND patients data. I’m unsure how to treat the data being gathered from these patients which now includes over 25 patients. Can CYDY use this persuade the FDA before data from the approved trials mentioned above are complete? Seems less likely given NP’s comments earlier this week when he said they needed to go the trial route opposed to emergency approval from EIND data.
So, based on the speed of enrollment, the trial protocols and feedback on emergency approval based on EIND data, it’s seems June may be the earliest that approval for COVID could come. June is assuming trials enroll more quickly then they have been and it also assumes that no emergency approval will be given.
I think we need to have a discussion on realistic timelines in regards to approval for COVID. At this point, a couple of weeks seems unlikely given a number of factors:
1. Trial enrollment speed - Trial enrollment has been slow over the past two weeks because of the administrative process required at each hospital. I expect both of the COVID trials to increase in terms of speed, but I still don’t see the 75 patient phase 2 for mild/moderate fully enrolling for another 2 weeks or so (I believe NP set a similar timeline in a recent video). CYDY is a small biotech competing for trial patients with other BPs. I don’t expect the severe trial to fill any quicker unless the main hospital(s) participating in the trials are in NY or CA and involve doctors who have participated in the EIND. You’d think with hundreds still dying each day in NY, CYDY could fill the trial in a couple of days, but again, I think the administrative side of the trial and CYDY’s small size and limited cash prevents this from happening.
2. Trial protocols
The primary endpoint for the mild/moderate trial is clinical improvement at 2 weeks with a multitude of secondary endpoints at 2 weeks as well, including incidence of hospitalization, duration of hospitalization, and the same for ventilation. Once the last of the 75 patients is enrolled, a two week clock starts until data from all 75 patients is collected. Add another week or so for the data to be analyzed and prepared for submission to the FDA. So let’s say 3 weeks from enrollment of the 75th patient. This trial, as of today, has 15 patients enrolled in it after the first two patients were enrolled on April 6th. Hopefully, like I said above, this trial will completely enroll in 2 weeks as more centers are added. If it does, we’re looking at mid-May or June for full data.
The severe trials primary endpoint is mortality at 28 days and the secondary endpoint is 14 days. For that trial we’ll need at least 1 month of data from 50 patients before interim analysis. If those 50 patients are fully enrolled 2 weeks from now, CYDY could have interim results in late May or early June, depending on the time needed to analyze it. The question here, as outlined above, is how quickly can those 50 patients get enrolled.
3. EIND patients data. I’m unsure how to treat the data being gathered from these patients which now includes over 25 patients. Can CYDY use this persuade the FDA before data from the approved trials mentioned above are complete? Seems less likely given NP’s comments earlier this week when he said they needed to go the trial route opposed to emergency approval from EIND data.
So, based on the speed of enrollment, the trial protocols and feedback on emergency approval based on EIND data, it’s seems June may be the earliest that approval for COVID could come. June is assuming trials enroll more quickly then they have been and it also assumes that no emergency approval will be given.
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