NorthWest Biotherapeutics Inc (NWBO)

[Maverick0408]

“a lot of BLA rolling submissions have a mandated quiet period.“

Just do a simple Google search with some keywords and you will see a ton of PR from companies undergoing project orbis review before approval is granted. I post one such link below!

Even if NWBO has decided to adhere to a quiet period during rolling submission, which is prudent, there is no stopping them from making a public announcement once the application is formally accepted. No more so called quiet period from that point onwards! The 6 month FDA cycle starts from that point on. And MHRA is typically 10 months from what I have seen. There is no shortcut, unfortunately.

https://www.thepharmaletter.com/article/fda-and-ema-accept-filings-for-tebentafusp-in-metastatic-uveal-melanoma