The way JP was speaking about the FDA meeting in the webcast indicates quite strongly that approval will not be a problem. Firstly the results were fantastic. The side effect profile was also very low. The prevalence of diarrhea is a tolerability issue, not the sort of side effect that will force the FDA to reject the NDA. ACADIA was already aware of this side effect and has compiled a management plan. A very large number of participants also continued into the LILAC extended trial, which proves patients and their families are finding the drug to be effective.
For the ROW I think we should find a partner before the application. We already are in a position of strength because ACADIA are well aware this is getting through the FDA. Imagine the pressure ACADIA would be experiencing if NEU announces a new partner. They would be forced to go straight for the take-over offer at one hell of a premium if they really want to own ROW. I agree, it can never be a 100% chance that the NDA will pass, but it can be damn close, so it will be up to them if they want to take that risk. If they don't try to take us over then our share price will simply implode once this passes the FDA, as JP stated, the US is the most important market because the rest of the world basically follows the FDA. Getting approval from the FDA will all but guarantee we also get approval with our new partner's country/countries.
I agree on the valuation. If there is ever a time where a stock is worth it for the really long game, this is the one. The possibility that Neuren could transform into something much bigger along with just fantastic financial possibilities and certainties in the shorter term (2 years) is just so exciting.
NEU Price at posting:
$3.81 Sentiment: Buy Disclosure: Held
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