As I continue to delve into PPHM I have formed some new opinions and made some observations:
1. Amy seems to definitely be gone.
2. Jay Carlson seems to have been a temporary replacement for Amy.
3. PR/IR will be taken over by Chris Keenan. CK seems to be a knowlegeable guy with 15 years experience in biotech PR.
4. IMO only, because of the practical difficulty running a "placebo arm" in a Cotara Phase III (you can't drill somebody's skull and pour in water), partners will need an SPA from the FDA to proceed with confidence. This changes my outlook slightly. Prior, I thought it possible that PPHM could get a phase III approval without necessarily getting an SPA but, I now think this is less practical. I like this better to the extent that "if" an SPA is achieved then Cotara is much more easily partnered and will probably command a better commercial deal. Again, IMO PPHM regulatory team is hard at work along these lines. IMO at some point PPHM will have to move from written iterations back to the aforementioned sit down meetings with the FDA. This is in line with many long term comments on PPHM seeking an SPA.
5. IMO there should not be as much difficulty in licensing Hepc without interfering with the cancer franchise as I had feared. IMO,if Hepc were to be licensed it could be done in different formulations than a cancer treatment.
6. Again, IMO only, I come down on the side of the argument that not only is bavi safer than interferon but that the "trend in extended periods of time" may prove greater efficacy as well. There is a lot of experimentation that has to be done here and a partner is needed. My opinion will only be validated if and when PPHM partners viral. However, I am greatly encouraged by the idea that such a license would not interfere with the cancer franchise.
Best Regards,
RRdog
