Great points, have to speculate as to the FDA’s
Post# of 155271
(Total Views: 735)
Posted On: 09/07/2020 1:24:25 PM
Great points, have to speculate as to the FDA’s flip flop on WRO and our Type A meeting request. Here is my guess:
- WRO, means a “Written Response Only.” As I recall, this was the FDA’s preferred way of answering in lieu of Cytodyn’s request for a Type A meeting.
- Type A Meeting: “Immediately necessary for an otherwise stalled drug development program to proceed.”
Looks like the FDA, for whatever reason, may have “changed it’s position” on some of their WRO responses. This necessitated an immediate issuance for a Type A meeting, Sept 9th.
My guess is that their WRO sent to Cytodyn was delaying us again. No shock here. However, all the publicity around their unreasonable redirecting us again and again may have elevated their response a internal review of their WRO especially with NP’s bypassing them and reaching out to the UK!
Now they need to reset their WRO in a face saving manner. Easiest path is to finally (!) give us the combo approval as a token win. Combo preserves big pharma’s cocktail of current HIV drugs revenues! Dosage, most likely will be 350mg, consistent with UK filing.
So this preserves the FDA acting before UK does
and we get our BLA! Mono will get new delaying FDA requests as this otherwise would crimp big pharma big time. With BLA, we are poised to deliver LL for other off label indications as well. May also include some MM emergency usage for the Covid plague, but dosage maybe an issue? Who knows.
Can’t wait for the unblinding of the severe to critical test results by end of September and public results by mid October.
- WRO, means a “Written Response Only.” As I recall, this was the FDA’s preferred way of answering in lieu of Cytodyn’s request for a Type A meeting.
- Type A Meeting: “Immediately necessary for an otherwise stalled drug development program to proceed.”
Looks like the FDA, for whatever reason, may have “changed it’s position” on some of their WRO responses. This necessitated an immediate issuance for a Type A meeting, Sept 9th.
My guess is that their WRO sent to Cytodyn was delaying us again. No shock here. However, all the publicity around their unreasonable redirecting us again and again may have elevated their response a internal review of their WRO especially with NP’s bypassing them and reaching out to the UK!
Now they need to reset their WRO in a face saving manner. Easiest path is to finally (!) give us the combo approval as a token win. Combo preserves big pharma’s cocktail of current HIV drugs revenues! Dosage, most likely will be 350mg, consistent with UK filing.
So this preserves the FDA acting before UK does
and we get our BLA! Mono will get new delaying FDA requests as this otherwise would crimp big pharma big time. With BLA, we are poised to deliver LL for other off label indications as well. May also include some MM emergency usage for the Covid plague, but dosage maybe an issue? Who knows. Can’t wait for the unblinding of the severe to critical test results by end of September and public results by mid October.
(3)
(0)