NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

In this link provided by Flipper you will find an article where you will read that Pfizer, Amgen and Janssen are seeking further clarity as recently as Dec 3 2021 on the guidance. https://endpts.com/pfizer-amgen-and-janssen-seek-further-clarity-on-fdas-new-benefit-risk-guidance/

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

So if the questions in the article as raised by these BP are the last comments then the change of a further wait has actually increased and not diminished before that guidance will come into effect. This is the FDA thus it could be very well be so that it could still take many months.

If NWBO is waiting for the guidance Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; first before we will see the publication/TLD then we may well be in for a very very long wait still. The FDA really dont give a dam.

Im pretty very sure NWBO is NOT waiting for this guidance, why should they?