Pinned straw:
Before answering my own question, I just want to say what a joy it is listening to CEO Jon Pilcher in his investor presentations. He is incredibly candid, being explicit about what information he cannot give and why. In the 1hr 7min call, he must have spent a solid 40 minutes on Q&A. Going through question by question, grouping similar questions, but also reading out unique questions. So you come away learning a lot.
Now to answer my question about the Type C FDA meeting coming up in April:
Jon felt that the question (mine and others) mischaracterised what he'd said last year. He said that when asked last year he believed it should be possible to resolve the endpoint issue with the FDA by email without a meeting, but ultimately he couldn't speak for the FDA. He conceded that his confidence proved unfounded, as the facts show. However, he explained that given that a PMS Phase III trial is a world first, there is no template for endpoints and ultimately no-one can determine where the FDA will land.
That uncertainty carries through to the Type C meeting. However, Jon conveyed that the submission had gone in and now there was a huge amount of work going on to prepare for the meeting.
My Key Takeaway
So what? Well, the outcome of the meeting in April is the next critical catalyst for $NEU. If they proceed to Phase 3 AND the SP is in the vicinity of where we are today, I'll likely increase my holding by 50%, taking back the 33% I sold last year when the SP was >$20. (There's a chance I can get in in time.)
My views on valuation are unchanged, although the positive progress of DAYBUE in the last quarter means that the likelihood of my $12 downside valuation has probably fallen significantly.
Disc: Held
Thanks @mikebrisy for your your review and takeaways.
I agree, I really enjoyed Jon's presentation and how he took the time to address the questions and was a bit more measured with responses to set clear boundaries on what could be discussed whilst still being informative. This meeting was so engaging that I ended up running late getting back from my lunchbreak
On top of what you have added, I just wanted to add a few more takeaways from my perspective which I appreciated:
- There wont be a huge timelag between the PMS, PTHS and AS Phase 3 trials for NNZ-2591 commencing, and a staged approach will be undertaken given the significant startup efforts
- The Board were aware of the substantial franking credits in the bank, however Jon didn't want to distribute a once off dividend with current cash for now as the intention is to start dividends once continuity can be maintained.
- Neuren wouldn't be looking to manufacture NNZ-2591 and would likely look to enter into a similar partnership arrangement in the future.
- The company would be looking to maximise value and wont be rushing into a licencing deal straight away until the results of the trial were known. Companies have been approaching them already about NNZ-2591 but they will only do a deal now if an unbelievable offer was to come across the table.
- Neuren will be focussing on PMS at the upcoming meeting with the FDA, and looking to keep Angelman separate from this discussion to achieve the best outcome. The goal is to try tick off as many of the items in the table below where achievable.
In summary, everything still on track for now and will await the outcomes from the FDA meeting. Like Mike, I am holding my RL and SM positions steady and will reassess in April.