for both Craigakess and Jmcll. After the initial B
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Posted On: 05/02/2020 5:13:13 PM
Re: craigakess #31563
for both Craigakess and Jmcll. After the initial BTD in january, the FDA came back and told CYDY they need to do a preliminary meeting because they only filed the 2 patients and they need more data. So they have requested that preliminary meeting
https://www.cytodyn.com/newsroom/press-releas...eeting-for
NP said it was a no go on the initial because not enough patients in the early March conference call (I think) or a super stock. I don't remember which one, but it was somewhere in there.
We await the preliminary meeting but Dr. Bruce should be there alongside NP and with 12 patients worth of data this time around vs 2-4. Even then I suspect this is just the FDA telling them, "yes we think you have something" or "no we don't think you have a chance". Since the FDA seems to be busy these days, not sure when the preliminary meeting will be or how long FDA has to respond. Maybe its the usual 60 days, not sure.
Hope that helps.
https://www.cytodyn.com/newsroom/press-releas...eeting-for
NP said it was a no go on the initial because not enough patients in the early March conference call (I think) or a super stock. I don't remember which one, but it was somewhere in there.
We await the preliminary meeting but Dr. Bruce should be there alongside NP and with 12 patients worth of data this time around vs 2-4. Even then I suspect this is just the FDA telling them, "yes we think you have something" or "no we don't think you have a chance". Since the FDA seems to be busy these days, not sure when the preliminary meeting will be or how long FDA has to respond. Maybe its the usual 60 days, not sure.
Hope that helps.
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