Thanks Crescentmotor, I certainly don't know, but I believe that the FDA is taking a more constructive attitude toward drug approvals, rather than insisting on additional trials prior to approval, I believe the could approve for both indications but insist on a conformational trial. If it were up to me Phase 4's would follow approvals with the prescriber simply reporting the new product working acceptably, as long as that was the case, but identifying any problems in greater depth.
We have friends with AD who remember us from decades ago, but don't remember we said hello 5 minute earlier. I really don't know what treatment they're on, or if AVXL's drug would be of benefit at this point, but hopefully it could be.
As I've mentioned, my biggest investment is now NWBO, I suggest having a look at it. They are making solid cancer vaccines from the tumor itself and while the trial was done in brain cancers, they've openly stated that the intention will be to go for a tumor agnostic label and they do have some data, mostly anecdotal, that it's a valid claim. At UCLA, where some of the development was done, they've used the vaccine in combination with Poly-ICLC and/or Keytruda and improved 5 year survival to over 50% in early trials, these drugs are ineffective in GBM without the vaccine. Normal survival at 5 years with the SOC is 5%, it's 13% with the vaccine but without the others, but certainly should gain approval for that. They've applied for approval in the UK where they can commercially produce manually in individual cleanrooms. The EDEN unit, which automatically makes the vaccine, is in the process of gaining approval, I suspect they want that before going to the FDA and perhaps other regulators involved in the Phase 3 trial, Canada and Germany. NWBO is believed to be a buyout target by many at over $20.
I'll take a look at SAVA, I've heard of it before but hadn't looked into it, thanks.
Gary
