Replies to post #627007 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

The FDA has clearly been the world leader on modernizing the drug approvals process.

They are the fastest.

They were first to introduce various fast track programs.

They introduced Orbitz which allows laggers like the UK and Canada to piggyback off FDA reviews.

They introduced RTOR that allows the review of the data to start before the sponsor can complete a submission.

The complaints on message boards such as this are from disgruntled investors.

[dennisdave]

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.
https://finance.yahoo.com/news/outlook-therapeutics-provides-regulatory-fda-100000177.html

the Agency concluded it could not approve the BLA during this review cycle due to several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence

I do not believe that the delay in submitting a BLA to the FDA has anything to do with consultants being slow, politics or data not being in order, it has everything todo with manufacturing capacity at Sawston or even CRL. Lets hope that NWBO's manufacturing capacity is in order after MHRA approval or otherwise we are in for another long wait after MHRA approval until the capacity or quantity is at the level it meets FDA criteria.