Replies to post #817899 on NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

NWBO has repeatedly avoided reporting FDA actions. They refused to explain why the FDA put their P3 clinical trial on a partial hold -- clearly a material event. They avoid any questions as to the cause of the partial hold.

Northwest Biotherapeutics has not publicly reported any substantive details of the content, questions, or FDA feedback from its post–Phase 3 Type B meeting regarding DCVax-L. Public disclosures in press releases, corporate web materials, and recent SEC filings discuss the Phase 3 results, regulatory strategy, and general plans for pursuing approvals but do not summarize or quote the Type B discussion, positions taken by FDA, or specific guidance received.

NWBO applied and receive approval for U.S. orphan designation which is only available as a U.S. FDA authorization process. But again, NWBO has not filed for approval after the Type-B meeting discussion either.

[HyGro]

NWBO does not communicate bad news with their shareholders. The refused to provide any SEC filing or public response as to why the FDA placed a partial hold on their P3 clinical trial. This is clearly a material event and they refused to explain anything about the FDA action.

NWBO had the Type B meeting as all biotechs do after completion of P# trials. But once again made NO public communication about the outcome of the meeting.

Bottomline, NWBO has chosen to be silent on the facts that indicate that FDA would not accept an application for approval based on the P3 trial data.