Ann: Phase 2 trial shows significant improvements in Pitt Hopkins, page-152

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nashezz

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28/05/24

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Post #: 74043645
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Originally posted by baldwidx ↑

Eagle - I wonder if you or some other posters might have more insight into the following.

Do you know if you can go straight to a P3 trial for an indication, in a drug that has been proven to be safe and effective? For example, if we get PMS and PHS through registration and into sales, presumably the FDA has deemed the drug to be not just effective v placebo, but safe.

JP referenced this yesterday when he mentioned not needing to undertake P2 trials given they are mainly used to determine dosing and safety. If we take appropriate dosing as a given, following his comments and if we take safety as a given, especially if we took one or both conditions through registration, then is it possible that we have a "straight to P3" pass?

If that is possible, then I think that SIGNIFICANTLY changes the landscape for Neuren - I can't see a TO being accepted unless its absolutely astronomical - numbers we don't even dare to discuss. Why would you not run through P3 after P3 yourself and keep all the profit??

if you have sufficient funds in the short term to run the PMS and PHS trials through to marketing, you may need a small CR (pending updated Daybue Revenue) to keep the lights running but you would quickly bring in so much money from those two that can be reinvested into AMS and then PWS and so on.

It really does shift the paradigm but I guess its all predicated on whether a "straight to P3" scenario is possible.

Has anyone come across it before in a similar platform drug?

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It appears the answer to your question is 'Yes, you can skip' as detailed in attached paper. You can also do combined Ph2/3 trials.

https://www.sciencedirect.com/science/article/abs/pii/S0895435623000793

NEU Price at posting: $23.45 Sentiment: Buy Disclosure: Held
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