The 12 month durability for HSV2 viral shedding, recurrences, and lesions is most impressive and makes it very promising for P-3 trial confirmation. Unique antigens and adjuvant Anybody on Valtrex or Famvir wuld likely get this therapeutic vaccine. pps should easily be back over $8 like it was when the news came out late March.
This tech was tried in 2008 (Asklepios Biopharma) and resulted in auto-immune adverse reactions (published in NEJM in 2010). Anytime you give a live viral vector and potential for a foreign gene to create a mutant, there are safety issues. Lots of clinical trials and time will be needed by Bamboo to demonstrate safety (at least 5 yrs before ever gets FDA approval).
A lot of people like yourself (and some even within FDA, like Dunn/Farkas crew) have not yet understood that FDASIA was intended to create a new class of drug approvals. These conditional approvals ("accelerated approval") would temporarily have a lower standards bar but eventually would need a confirmatory study otherwise be withdrawn from the market. You cannot compare this to historical standards. Expect to see many new FDASIA applications.
You are wrong, and Bionerd is correct. FDA does lower the standard of evidence for a brief period of time until it is fully studied perhaps with some more endpoints (higher standard) in a confirmatory P-3 trial. That is the FDASIA law that Congress & the public intended. The problem is its uneven application within the various review divisions of FDA and the etep ruling - if negative - will be a major issue on review standards for the new FDA Commissioner. The world changes and FDASIA kicked it off ....time for everybody at FDA to adhere to the new process & standards.
Pfizer is on the hunt to expand their profitable vaccine biz and gen-herp vaccine is on their shopping list. Pfizer office in Cambridge too. The key is the unique Matrix-M adjuvant that makes this an exceptionally successful vaccine as seen in recent P-2 results.