Hi Garra, welcome to the forum group! Neuren have not started...

Hi Garra, welcome to the forum group!

Neuren have not started Phase3. Yes it will be 6 months long and the method/validation process is agreed with the FDA. The FDA have requested that Neuren complete a 2nd species chronic toxicity study. My understanding is that this is 6 months long and should be complete reasonably soon if they got started in November (not expecting any issues).

I don't think Neuren have enough cash to run the P3 trial as it is. The Lanstead deal looks enough to manage the operating costs but I am pretty sure they couldn't fund P3.

So the market is waiting on Neuren to provide guidance on how they will fund P3, either through a market capital raise, a Lanstead type funding deal or some form of partnering/merger arrangement with big pharma.

News on this was expected Q1, now Q2 - but in reality there is not time frame. Neuren have stated that one of their primary aims is to get Trofinetide to market asap, so I don't expect they will drag their heels, but they also won't undervalue their asset to get things moving.

With an annual report and AGM by mid year, there has to be something brewing one would think.