So Anavex changed its endpoint to new surrogate endpoints post hoc data collection AND on top of that switched to endpoints not generally accepted by the FDA...
Good luck with that
There is a reason the markets were not impressed with Anavex's PR yesterday.
IMO Anevax's only and best way forward is to convince the FDA to buy in their new endpoints/SAP and after that start a new Phase 3 trial
Someone who gets his information from chat GTP is the one confused and can not be taken seriously that's you Atlanta junior. I have been invested in NWBO for 8 years now. The date you see in people's profiles has nothing to do with how long they are involved in NWBO simpleton. After explaining these basics to you, I will repeat the other basics I had to teach you.
You stated that there is no guidance for external control arms (ECAs) implying NWBO has no choice but to wait for external control arms (ECAs). That was FUD and a bearish post on your part.
Then thankfully for you, I corrected you by saying
You are wrong on the 210 days and wrong on the clock starting on the acceptance of the submission
Just want to add that the 150 CALENDER days from the day the application is SUBMITTED, does not necessarily mean the time to approval is 150 CALENDER days. It may also very well mean that the MHRA will conclude well before the mentioned 150 days they have come to the conlusion to approve DCVAXL. The MHRA knows DCVAXL very well they have approved MIA and approved compassionate use.
The timeline is 100 days (average 80 days) NOT BUSINESS DAYS after the MAA has been SUBMITTED in RR or 150 days SUBMITTED if they are NOT in RR
I recommend you read this
Anything else then rolling review has been highly discouraged by MHRA since January 1 2021
the link I provided actually does say that: We recommend you email AcceleratedandRollingReview@mhra.gov.uk
The pre-submission meeting should be requested at least 90 days before the intended submission date. The meeting request should be made via email at AcceleratedandRollingReview@mhra.gov.uk
Your explanation is correct other than "OS is not the "gold standard""
Assuming they submit Oct 1 and assuming the MHRA accepts on Oct 14 then its 100 days (not business days) so Jan 2024 on the condition that the MHRA will not request additional information from NWBO after 60 days with an RFI response. If the MHRA requests all kinds of additional information and raises additional questions and NWBO takes it usual snail's time to respond then the final MHRA decision could go well into 2024.
If NWBO gets fast-tracked and no RFI are raised then the decision may be taken within 80 days so that would mean in dec this year. But with out turtle luck... Im not counting on it
The FDA will have no problem approving DCVAXL on present RWE and SPA as currently presented by NWBO. The FDA could however decline a request for approval if NWBO does not have its production in order as it declined Outlook Therapeutics BLA.
I can tell you have little business experience
NWBO will NOT commit itself at present (and Merck will not agree) to start combo trials with Merck if NWBO has to pay for a (part) of the combo trial.
The reason is that NWBO has NO money in the bank and only debt.
Since they are now in active discussion that can only be on the condition that NWBO is paid to enter the combo trials with Merck.
end of discussion
everything you write about DCVAX being effective and the medical greatness of the drug is all good and great but has nothing todo with the subject
But the share price is not $5 now is it? NWBO Clearly stated they are in active discussion with a large pharma to agree on the combo trials. We are hearing that any day we could receive a PR they have agreed on the combo trials .
You cant seriously assert that Linda Powers would gamble that someday the SP may or may not be $5 to then be able to sell shares to pay the hundreds of millions needed to finance the combo trials and thus sign that deal now with Merck. That's not managing NWBO that's gambling. And oh then there is also the 150 million they need to build a sales team to sell/ sales support DCVAXL. How are they all going to pay for all of that?
I can assure you Merck legal will not accept NWBO's commitment to paying hundreds of millions for the combo trial with 20 cents in NWBO's bank account.
No Linda will not gamble on a future SP to finance combo trials and thus gamble NWBO, she will have agreed to upfront payments. And yes shareholders would mind diluting another 100-150 million shares if they could have been much better off by being paid hundreds of millions by Merck.
NWBO will be bought right after MHRA approval.
If DI thinks 150 days until approval is AA than he should get a new job
new applications typically take 90 working days to process
variations where no inspection is required: 30 working days - variations where an inspection is required: 90 working days
new applications for registration as Active Substance manufacturers, importers and distributors take 60 working days - if an inspection is required: 90 working days