Replies to post #359821 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

The FDA (and others) absolutely do not care about PRs or journal publications.

They will have the full trial data. Not just database but the actual records. They will vet the details against the locked database. They might even have their experts re-read scans.

Then they will have their stat team run the SAP against that database. And then run it the way the FDA thinks it should have been. And then with all sorts of "what if" games.

The idea that any sort or PR or journal paper affects the process is for tools.

[ATLnsider]

Bob_LobLaw, I disagree that this loan for $11 million means that the new DCVax-L BLA process has not already started. Especially if the DCVax-L top line data (TLD) is as good as we all believe it is.

I believe that the FDA is the lead regulatory agency (RA), and it will review the DCVax-L TLD first. I am already on record stating that I believe NWBio may already be using the new FDA Real-Time Oncology Review (RTOR) program, that allows new and supplemental drug & biologic applications to be submitted, reviewed, and approved faster. NWBio only has to submit the DCVax-L TLD to the FDA to get the DCVax-L BLA process started via RTOR.

https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review-pilot-program

In fact, the average time from submission of a new BLA or NDA to FDA approval was 3.3 months under the FDA RTOR program:

https://clincancerres.aacrjournals.org/content/27/1/11

DCVax-L is perfectly suited to take advantage of the FDA RTOR program.

The FDA’s Real-Time Oncology Review (RTOR) pilot program aims to create a more efficient review process that ensures treatments are made available to patients as early as possible. The FDA Oncology Center of Excellence launched RTOR in 2018 to allow sponsors to submit clinical data supporting the NDA as they become available, rather than waiting for the full NDA. This effort is a testament to the importance that regulators have placed on advancing innovations for cancer patients

https://www.amgen.com/stories/2020/12/decoding-5-recent-regulatory-and-development-steps-for-sotorasib

The FDA oncology group is clearly reinforcing the very deliberate message that cancer patients would not be forgotten even as the pandemic became public health priority number one.

It is, however, in keeping with recent efforts in the Oncology Center of Excellence to innovate and accelerate regulatory processes. Most notably, the adoption of so-called “Real Time Review” is clearly accelerating the timeline for action on cancer applications with unequivocal efficacy results.

So ahead of schedule approvals are also becoming almost routine in oncology. The various cancer divisions at FDA approved 10 new drugs more than a month early in 2019 and seven in 2018.

https://pink.pharmaintelligence.informa.com/PS143715/US-FDAs-Three-Review-Speeds-Standard-Priority--And-Oncology

Not only do I believe NWBio may be using the FDA RTOR program for DCVax-L, I also believe NWBio may be using the FDA new Project Orbis program in conjunction with the RTOR program.

The FDA Oncology Center of Excellence (OCE) established Project Orbis to allow for the concurrent submission, review and approval of new oncology drugs and biologics in 6 different countries, by 6 different regulatory authorities at the same time.

These countries include: US, UK and Canada. I believe that DCVax-L could be approved in at least 3 different countries at the same time, and within 3 to 6 months from submission of the completed & accepted new BLA.

Project Orbis is intended for high-impact oncology products – those products that have the potential to benefit patients the most. A driving factor behind establishing Project Orbis was to bring highly effective therapies to patients with cancer earlier, especially in countries where there would otherwise have been delays with regulatory submissions. Companies with applications seeking to participate are generally expected to meet the criteria for FDA’s priority review, which include a medical product that is intended to treat a serious condition and that, if approved, would provide a significant improvement in safety or effectiveness.

https://www.fda.gov/news-events/fda-voices/project-orbis-strengthening-international-collaboration-oncology-product-reviews-faster-patient

[flipper44]

Bob_LobLaw Friday, 03/05/21 06:08:32 PM
Re: jm100 post# 359809 0
Post # of 359930
DI is informing some investors that they are working on a journal which will help support the agency applications. Other investors get told "refer to Oct 5th PR"