NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

The only problem with this is you are relying on this mgmt team to be able to actually submit and reply successfully to the RFI requests from two agencies. And not even knowing that the application needed re-work becuase they were scared to submit PR about BLA/MAA rejection. This may take a few years.

I do believe the last 10Q when they said this "Additionally, substantial progress was made with the CRO and specialized consultants on preparing the Trial Master File to be inspection-ready for regulators."

I also believe and have heard via my friend in my NWBO group (as Thermo said) they are very close to being accepted by the MHRA. So really weeks not months let alone years. Now after MHRA has accepted the application, the Trial Master File is not THAT far off to then also be ready to submit to the FDA again in weeks not months let alone years. Also, my sources told me they plan to submit to the FDA right after MHRA.

So summarized yes they are slow as mud, they source everything to consultants, but in the end, as in with TLD and JAMA they will deliver the requests for approval to all RA's (EMA last).