NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

the FDA requires that the Sponsor gives the TLD to the FDA first, before it is released to the general public.

I dont think that is the case. The timeline for the RTOR pathway is at least one year. That would mean that the FDA encourages biotechs opting for RTOR to deliberately ignore another FDA rule § 11.42 to submit topline data one year after the primary completion date.

So I cant imagine the FDA asking that I have not read anything like that

In general, for applicable clinical trials subject to § 11.42, clinical trial results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)) or in § 11.48, as applicable, must be submitted no later than 1 year after the primary completion date of the applicable clinical trial.
Source: https://www.law.cornell.edu/cfr/text/42/11.44#b_1