Things still have progressed a great deal through Tanzis work since then. I don't think they would want to update on any FDA matters until we get that company halt news telling us of the FDA decisions post handing in the PCH submission.
If it does get off the ground there will be lots to
discuss :
1. Potential 3 trials running at once - phase 3 for AD,HD & phase 2 for PBT434. What will the biomakers/endpoint look like? Initiation dates of trials?
2. Discussion around funding of those trials. One good thing about this submission is if FDA approves it can be utilised to source big pharma partnerships. I can see capital influx coming on quick if we get FDA and EMA on board. Worry is potential buyout at cheap prices. Another would be future grants from disease foundations - we need a white knight to help fund these massive trials. Shoulson needs to have a chat to Bill Gates. Any new grants will help accelerate the realization of potential.
3. With phase 3 protocols to be worked on as we speak, there must be a high degree of confidence it will get the green light. We might get information on why it was placed on pch hold and why it took so long
4. Where to with current executives? If partnership comes along, they wont put up with dithering slow progress.... I'm guessing people will need to shape up to deadlines or move on
5. There of course the real potential of FDA saying no again and the outcome of that. What for pbt2 in US and what jurisdictions to target after that?
Any other things that others feels might arise post PCH news feel free to add...
Just all speculation on my part and DYOR prior to investing in any company.[/QUOTE]
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