A Look at The FDA's Fast Track InformationEarlier today I made a
post about where The Money might come from. This is a very serious post. I think it's important to read it very carefully. There is sime serious shot in there.
In the post I stated that the FDA can and does invite companies to apply for fast track approval. Let's look at the FDA's descriptions of fast tracking and then at the part about The Suggestion.
On their website, the FDA presents overviews of its fast track processes, first on a cover page that provides links to the other four pages that go into detail. The pages are brief, brief enough that I can't summarize then much better than they already are.
The main page, found
here), lists the links to the four fast track approaches.
The four approaches are:
1. Fast Track (found
here)
2. Breakthrough Therapy (found
here)
3. Accelerated Approval (found
here)
4. Priority Review (found
here)
Of the four FDA approaches to fast tracking, number 2, Breakthrough Therapy, is the most obvious one that fits xB3-001. The fact that Herceptin is so well known, and that treating brain tumours is so close but for the BBB, are the compelling arguments for Breakthrough Therapy considerations.
Also of note is that Breakthrough Therapy gives the drug's sponsor (or developer) access to the other three approaches. In other words, every fast track approach is available to the drug's sponsor if it gets Breackthrough Therapy ststus.
In addition, the Breakthrough Therapy is the only approach where the FDA may suggest that the drug's sponsor should apply for fast track consideration. The paragraph, on the Breakthrough Therapy page, states:
"
Breakthrough Therapy designation is requested by the drug company. If a sponsor has not requested breakthrough therapy designation, FDA may suggest that the sponsor consider submitting a request if: (1) after reviewing submitted data and information (including preliminary clinical evidence), the Agency thinks the drug development program may meet the criteria for Breakthrough Therapy designation and (2) the remaining drug development program can benefit from the designation."
The Breakthrough Therapy designation requires that the FDA gets involved with the sponsor at an early stage. The timing of the Bioasis statement and that the Bioasis statement references Phase 1, leads me to consider the possibility that Bioasis has already received that "suggestion."
jdstox