Ann: Appendix 4E and Annual Report 2015, page-28

@interestingtome....thank you for all your comments and summary of available news/research out there..your short/sharp and shiny take on things is much appreciated...

.there was so much new information in that Annual Report...and it is a very hard read for an average person . The new bits which were already discussed and highlighted here were very positive imho. And it looks like they already prepared all data from old and new research and are ready to be submitting it to FDA to have the PCH removed...and all that work will go a long way to benefit us in so many other ways in the future...just to quote:

" To have this limitation removed, the FDA has required us to establish how the dog study is not relevant to future PBT2 trials in humans or, to describe a strategy to safely proceed with clinically relevant dosages in future clinical trials with PBT2. Whilst our response to the FDA requirements has the proximate goal of removing the PCH, we have used this exercise more broadly to create a strong clinical and non-clinical package of data, and its interpretation, to facilitate clinical and commercial development of PBT2, not only in
the United States but globally and for both HD and AD. The process for assembling this package was facilitated with the appointment of third party specialist pharmacometricians, clinical safety physicians and clinical pharmacologists. They have undertaken extensive safety analyses to characterize the behaviour of PBT2 drug exposure in the dog and human and how this translates to the comparative safety profile in the dog relative to humans. Based on the emerging strong safety profile for PBT2, we are preparing a robust safety monitoring
plan for future trials in HD. These plans will be submitted to the FDA as part of our response and the combined FDA non-clinical, clinical pharmacology and safety analysis package will be used in submissions to European and other regulators in support of our global development plans and prospective marketing approvals."

I am (again) quite positve that we will succeed and we will see our compounds (PBT2/PBT434) on the market in near future...;-) ...patience will be rewarded..