NorthWest Biotherapeutics Inc (NWBO)

[CrashOverride]

As you all know PII approvals can happen on stellar data especially for those treatments which have no side effects treating orphan diseases. We know of CAR-T approvals for example as a comparison though these are being restricted now due to sometimes fatal side effects. For DCVax with PolyICLC regulators could simply require a confirmation trial post approval which would be easy to recruit given the amazing PII data.

The PIP includes non GBM patients therefore it seems like we are applying for all brain tumors in the UK not simply recurrent and newly diagnosed Glioblastoma patients. MHRA are not going to experiment on children with therapy not approved in adults.

In my estimation it makes sense that NWBO management would apply for approval with PolyICLC, not simply as a monotherapy alone, since they had this amazing data in hand well before December MAA submission.

They may not have disclosed this effort since they have no idea how the regulators would act therefore it could be misleading to inform the market of such an uncertain outcome. Regulators are most concerned about providing an honest perspective to the market while management may believe approval on PII a relative long shot given the smaller sample size verses PIII monotherapy trial.

Yet I firmly believe this was attempted in the MAA as it makes sense to leverage limited resources for one large effort at once as opposed to going back to regulators post DCVax monotherapy approval. With high confidence we can speculate the Mechanism of Action proteomic data was included in the MAA so I am fairly confident same for PII PolyICLC combination trial data.

Does anyone agree with this possibility?

Much credit to ATL who has been saying this for some time:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173058182

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173058318

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173061962