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Posted On: 02/19/2022 11:47:49 AM
Post# of 148902
Re: chazzledazzle #118597
"What if the Nash 700 numbers were great, they filed for BTD, and there waiting the 60 days for the FDA response?"
WhatIf raised this question in post#118581. I can't get it out of my mind.
What if at the same time we re-filed the mTNBC BTD Application with the updates median Overall Survival numbers? And are waiting the 60 days for the FDA to respond to that as well?
The reason it's stuck in my head is that I can't think of one of the puzzle pieces we are currently in the dark about doesn't fit. And none of them eliminate it either.
Spit-balling, so add and subtract at will.
1. We haven't heard the NASH data
2. We haven't heard the updated mTNBC mOS numbers
3. Filing 1/2 BTD(s) are not material events that must be reported to shareholders
4. Revealing the 60 day FDA waiting period has in the past given shorts a timeline to stage an attack
4. Nader said he would step down when the time was right, and is quiet
5. Nader has been terminated apparently amicably. "We thank Dr. Pourhassen for his vision and passion..."
6. Scott said, "Now is the right time for the next phase of Cytodyn's evolution...regulatory approval and commercialization."
7. Scott said that no company with two BTDs doesn't get bought out.
8. Does a PDUFA date for HIV BLA add to the prospects of a buyout.
9. If a partner or buyer is in the wings, we could very well be under NDA
10. Fairbanks Welch steps in for bond, and to theoretically "protect" All Intellectual Property - keep it in the family, so to speak.
11. LH is a no-brainer - if a buyout were in the offing, it better be quick
12. Nobody's hair is in fire and they still order pizzas at the Cytodyn headquarters.
Also...while this next bit pertains to granted BTDs, I believe it also says the FDA will not disclose the existence of the application and approval process.
"18. Will FDA announce when a drug has been granted breakthrough therapy designation?
FDA will not disclose information regarding sponsors who submitted requests for or who have been granted or denied breakthrough therapy designation. Breakthrough therapy designation requests are typically submitted to an IND, and the FDA cannot disclose the existence of an IND, or any submissions that have been submitted to the IND, unless it has previously been publicly disclosed or acknowledged per 21 CFR 312.130(a)."
https://www.fda.gov/regulatory-information/fo...-therapies
Theoretically yours,
chazzle
WhatIf raised this question in post#118581. I can't get it out of my mind.
What if at the same time we re-filed the mTNBC BTD Application with the updates median Overall Survival numbers? And are waiting the 60 days for the FDA to respond to that as well?
The reason it's stuck in my head is that I can't think of one of the puzzle pieces we are currently in the dark about doesn't fit. And none of them eliminate it either.
Spit-balling, so add and subtract at will.
1. We haven't heard the NASH data
2. We haven't heard the updated mTNBC mOS numbers
3. Filing 1/2 BTD(s) are not material events that must be reported to shareholders
4. Revealing the 60 day FDA waiting period has in the past given shorts a timeline to stage an attack
4. Nader said he would step down when the time was right, and is quiet
5. Nader has been terminated apparently amicably. "We thank Dr. Pourhassen for his vision and passion..."
6. Scott said, "Now is the right time for the next phase of Cytodyn's evolution...regulatory approval and commercialization."
7. Scott said that no company with two BTDs doesn't get bought out.
8. Does a PDUFA date for HIV BLA add to the prospects of a buyout.
9. If a partner or buyer is in the wings, we could very well be under NDA
10. Fairbanks Welch steps in for bond, and to theoretically "protect" All Intellectual Property - keep it in the family, so to speak.
11. LH is a no-brainer - if a buyout were in the offing, it better be quick
12. Nobody's hair is in fire and they still order pizzas at the Cytodyn headquarters.
Also...while this next bit pertains to granted BTDs, I believe it also says the FDA will not disclose the existence of the application and approval process.
"18. Will FDA announce when a drug has been granted breakthrough therapy designation?
FDA will not disclose information regarding sponsors who submitted requests for or who have been granted or denied breakthrough therapy designation. Breakthrough therapy designation requests are typically submitted to an IND, and the FDA cannot disclose the existence of an IND, or any submissions that have been submitted to the IND, unless it has previously been publicly disclosed or acknowledged per 21 CFR 312.130(a)."
https://www.fda.gov/regulatory-information/fo...-therapies
Theoretically yours,
chazzle
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