NorthWest Biotherapeutics Inc (NWBO)

[churchill_21]

Nonsense, "preparation of the master file" should not take nearly this long. Buttoned up biotech/pharma companies knock these items out in months, not years with endless excuses. Look at the FDA's recent approval for Sarepta's Gene therapy for patients with duchenne. They presented results end of July 2022 (several months after P3 trial concluded) and submitted their application end of September. Yes, we know DCVax is different, but not 3 years post data lock different.

Listen, even if this ends up being a million pages, or 2 million pages, they have failed to get this product to market in an acceptable timeframe. They have had over a decade to prepare and scenario plan for this very moment, they should have been off to the races upon data lock. The typical NDA/BLA takes months from data readout. This is not normal, folks. They are clueless. There is no more excuses to throw at the botched handling of this product. Spoofing, scanning, broken scanner, MMs, AF, etc., it really doesn't matter, its all BS. Even if they submit today, this is still a timeline and communication failure owned by the NWBO leadership.