Replies to post #570908 on NorthWest Biotherapeutics Inc (NWBO)

[X Master]

Are you kidding us? All 4 RA's will accelerate approval. Now the Shorts are saying it will be approved but it will take years. BS.

[ae kusterer]

aesop(1https://en.wikipedia.org/wiki/Aesop%27s_Fables) : I just checked with Shadrach, Meshach, and Abednego (https://en.wikipedia.org/wiki/Shadrach,_Meshach,_and_Abednego) . Their mean estimate for MAA approval is 8/1/23.



Re: exwannabe post# 570905

Friday, February 24, 2023 9:50:21 PM

Post#
570908
of 570917
I would say 6 months is the normal timeframe for nda/bla submission and 12 months would be considered slow. And yes that timeline applies even if it is personalized immunotherapy. You can go check the historical timeline on Dendreon wikipedia. 1 year from top line data to US FDA approval. (top line in April 2009, FDA BLA submission in November 2009, and FDA Approval in April 2010). The sad part is the investors are used to the company missing timelines and now having no timelines. This is why there is all this speculation on where things stand.

[dennisdave]

I would say 6 months is the normal timeframe for nda/bla submission and 12 months would be considered slow. And yes that timeline applies even if it is personalized immunotherapy. You can go check the historical timeline on Dendreon wikipedia. 1 year from top line data to US FDA approval. (top line in April 2009, FDA BLA submission in November 2009, and FDA Approval in April 2010). The sad part is the investors are used to the company missing timelines and now having no timelines. This is why there is all this speculation on where things stand.

NWBO could have met those timelines had they stuck with CRL for DCVAX production.
But Linda decided to safeguard her and Les's pension first by building Advent a Toucan subsidiary financed by NWBO shareholders.

I seriously hope someone will sue Linda Powers for scamming NWBO shareholders.