NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

NWBO's SEC filings confirm that the FDA has not approved the P3 revised protocol. FDA Guidance requires the changed protocol be filed, but does not make any approval or rejection decision.

Management, under penalty of perjury has said:
"The statistical analysis plan uses external control patients rather than within-study controls. There can be no assurance that regulatory authorities will allow a product approval to be based upon this approach."

FDA is clear they only "comment" on protocol changes IF the sponsor requests one. The approval requirement is from the trial IRB that is independent from the FDA.

From FDA Guidance:
:Once an IND application is in effect, the sponsor of the application may amend the application as needed to ensure that the clinical investigations are conducted according to protocols included in the IND application. Sponsors are expected to submit protocol amendments for new protocols or changes to existing protocols before implementation of the respective changes. New studies may begin when the sponsor has submitted the change to FDA for its review and the new protocol or changes to the existing protocol have been approved by the Institutional Review Board (IRB) with the responsibility for review and approval of the studies. If the IND application sponsor desires FDA to comment on a submission, they should submit a request for such comment and the specific questions that FDA's response should address."

Nowhere does the FDA state that an FDA approval is required.