The Whens and Whys of Top Biotech M&A Deals, page-70

Pretty sure Neuren is capable of running a Phase 3 trial. They were running four Phase 2 trials and completed 3! How do you know Neuren doesn't have R&D infrastructure in place in the United States? Are you aware they have a vice president of translational research based there?

I think what Jon's getting at is from a regulatory standpoint, BP wouldn't get the drug approved any faster than what Neuren can. They might be able to run huge Phase 3 trials concurrently across multiple jurisdictions and so they have an advantage both logistically and capability wise, but they still have to grind through the regulatory process same as everyone else.

The FDA meeting is important for a number of reasons but the one reason that been rattling around in my mind is the size of the patient sample for the Phase 3 trial. I'm guessing it will similar to what Acadia have done, BUT given the improved efficacy of 2591 over trofinetide the FDA may agree to a smaller patient sample. If so this puts pressure on a prospective suitor: The FDA reaffirms the positive results from the Phase 2 trials by agreeing to a smaller patient sample, Neuren runs the trial with a reduced cost and is within their capability, it signals to a prospective suitor that this situation could be repeated across the other indications and also the undisclosed indications as well.

Remember, Neuren has already engaged a data management provider in the US to manage trial data (is it CINCINATTI?). Hire a CDMO and fire it up baby!