I think we are cut from the same cloth as far as t
Post# of 155142
(Total Views: 955)
Posted On: 09/06/2020 11:16:17 PM
I think we are cut from the same cloth as far as taking notes and keeping timelines blafarm! 
I don't in any way mean to downplay your conclusion but I am actually very curious to understand why this meeting was called. I have a hunch none of us, including CytoDyn, really know. Given that the "FDA clarified the items it needed" why then ask us to meet about those same items? To give further clarification? Perhaps. In the end they tell us once, clarify a second time and then do a review of our submission before it is submitted. Perhaps? Or there could be another reason. They have never seemed so willing to review and have meetings with us before. What changed? Could it be something to do with the EUA? Applying for HIV @ 350mg in the UK? If so, this could be very positive for us.
I mean, honestly, if you want to stonewall us, the best approach would be to make the answers to our questions vague, let us pay Amarex to go off and try something they think will meet what they are looking for, have them submit it and then send us back another RTF. But they aren't doing that this time. While it would delay us by "up to 30 days" to do their review, I think what I just described would be far more burdensome to us if that was their objective. I think we all look at any "generosity" suspiciously though. "What's the catch?"
As for the MHRA... I think that sounded really positive too. They asked for a meeting and ahead of said meeting needed all our "manufacturing, clinical and non-clinical" data for their equivalent of a "pre-bla" meeting. Again, they could ignore us...as they have since early in the pandemic...BUT...it would be a little odd to move at the timelines outlined by Nader and ask for these production oriented documents within 5 days if it's just to tell us to do a phase 3 in m2m.
Again, I definitely appreciate your skepticism. Hopefully towards the end of this week we will have a better understanding of all that is going on.
Let's enjoy this recent rise in SP and hope that we can uplist to NASDAQ ASAP. After the last couple of weeks watching the SP fall, I for one want to just take a few moments and enjoy the recent green days and all the potential that can come out of actual meetings with two different groups that have the power to give us approval. GLTA!
I don't in any way mean to downplay your conclusion but I am actually very curious to understand why this meeting was called. I have a hunch none of us, including CytoDyn, really know. Given that the "FDA clarified the items it needed" why then ask us to meet about those same items? To give further clarification? Perhaps. In the end they tell us once, clarify a second time and then do a review of our submission before it is submitted. Perhaps? Or there could be another reason. They have never seemed so willing to review and have meetings with us before. What changed? Could it be something to do with the EUA? Applying for HIV @ 350mg in the UK? If so, this could be very positive for us.
I mean, honestly, if you want to stonewall us, the best approach would be to make the answers to our questions vague, let us pay Amarex to go off and try something they think will meet what they are looking for, have them submit it and then send us back another RTF. But they aren't doing that this time. While it would delay us by "up to 30 days" to do their review, I think what I just described would be far more burdensome to us if that was their objective. I think we all look at any "generosity" suspiciously though. "What's the catch?"
As for the MHRA... I think that sounded really positive too. They asked for a meeting and ahead of said meeting needed all our "manufacturing, clinical and non-clinical" data for their equivalent of a "pre-bla" meeting. Again, they could ignore us...as they have since early in the pandemic...BUT...it would be a little odd to move at the timelines outlined by Nader and ask for these production oriented documents within 5 days if it's just to tell us to do a phase 3 in m2m.
Again, I definitely appreciate your skepticism. Hopefully towards the end of this week we will have a better understanding of all that is going on.
Let's enjoy this recent rise in SP and hope that we can uplist to NASDAQ ASAP. After the last couple of weeks watching the SP fall, I for one want to just take a few moments and enjoy the recent green days and all the potential that can come out of actual meetings with two different groups that have the power to give us approval. GLTA!
(11)
(0)