Replies to post #423410 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Yes the regulator chooses which treatments will be offered this opportunity and from what we know, L would be an ideal candidate. Then the company has 3 weeks to choose what they will do as far as participating AND manufacturing MUST be in place soon after ie Charles Rivers Labs/Cognate/Sawston. Thanks for sharing this with the board. Best wishes.

Yes, and as of today they have neither Sawston nor CRl.

So do you agree that the talk of the BLA/MAA's already being submitted is pre-matiure?

P.S.: They will need a contract with CRL which will be material and thus must be disclosed in 4 days. And there is no reason to assume CRL could be anywhere near ready in a few weeks. Just because they made DCvax-L 6 years ago does not mean they have been keeping that capability ready to go on a moments notice.

[hoffmann6383]

This is the dream. Project Orbis application that is going on right now and the company is under a confidentiality agreement. All speculation.

Because Project Orbis involves discussions on confidential aspects
of marketing applications, each participating RHA is required to have a
confidentiality agreement with all other RHA in the Project Orbis
working group. All written and verbal communications as part of
Project Orbis are subject to the confidentiality agreements and cannot
be disclosed without written permission of the FDA or the information
owner.
Selection of applications for Project Orbis is coordinated by FDA,
and initial queries received by RHA are referred to the FDA. Either the
FDA or the U.S. Sponsor, the primary contact for FDA, can propose an
application for Project Orbis once topline results are available from the
registrational clinical trial(s). FDA also requests the Sponsor to include the global submission timing and plan that includes the name and contact information for each of the Sponsors or Sponsor-affiliates responsible for the country-specific submissions. FDA then sends the
proposal (topline results and global submission plan) to the RHA to
confirm interest and availability for participation. Sponsors also
have the discretion to select the number of RHA (minimum of 2,
must include the FDA) for submission. After confirmation with the
RHA, FDA will confirm the global submission plan through the U.S.
Sponsor and designate the participating RHA formally as a Project
Orbis partners (POP) for that application. The Project Orbis
Working Group (POWG) for each application will consist of FDA
and the participating POP.

Also, of interest:

The median time gap for approvals for Type A applications between
FDA and the POP was 1.1 months, with 90% of the approvals
conducted within 2.4 months of the FDA approval date.