You are right LostOut; very unusual. Far fetched theories are my specialty – let me run you by one. My guess here as to the results?
A paradoxical result.
The P2b trial will not produce a convincing efficacy signal from the MBAci. This is a major problem because the MBAci is the primary outcome for the planned P3 trial. Without this signal it will be difficult for NEU to raise funds for the P3 trial (as it is currently designed) even with the Walker ATM.
So a bummer for shareholders. But so what. ASX speculators should only invest what they afford to lose.
Far more importantly the Retts community will feel decidedly ripped off. Their view will be that any drug which shows even the faintest promise should go through to a proper definitive test (P3). And in a sense this is perhaps an unspoken “pact” with drug developers; and drug regulators.
The compromise is a new trial design agreed with new FDA management that moves away from the traditional frequentistic inference type approach which has been agreed here for the P3 trial. The current approach appears to be pretty sudden death on p<0.05 on the MBAci based on a clinical threshold.
An adaptive type P2/P3 Bayesian clinical trial is more suited to both the commercial requirements (NEU will be able to raise funds for this; but not P3 trial where the P2b efficacy signal is weak) and hearing the consumer voice. This approach is also potentially more viable now using “priors” from the Retts natural history study.
The confusion between whether this trial is exploratory or confirmatory has occurred because the goal posts have moved during the trial. It has become more high stakes than originally intended. The design of the P3 study has been agreed; and the primnary outcome measure (MBAci) settled really before it all should have been.
Lets imagine this is what is happening; what does it mean in practice. Like every trial result NEU has produced in the last few years the results will be very much in the eye of the beholder. This will be no different.
And so share price wise; anticipating the anticipations of others?
It might not be the prettiest way to have got to P3 but I think NEU will be there; on very much a “exploratory” efficacy signal; from both studies taken together. But the decision will be as much about the heart as the head. And so it depends a little bit which nerve ones hip pocket is most closely connected to.
NEU will put their best foot forward in the announcement this week. Encouraging signals of efficacy on one thing or other will be produced with jiggling and poking. NEU will report a very positive and productive meeting with the FDA where the P3 trial was tweaked. Onwards and upwards kind of thing.
Share price will rise but not in “rerating” type of way. More a wealth transfer type event. A couple of weeks later people will be mumbling about how Australian biotech is undervalued etc. The company will waffle on about talking to half the worlds pharma companies; HC posters will continue to google away.
But the paradoxical nature of this is that it will be from failure that the bar is lowered and the probability of success in a P2/P3 is increased. This is a better result than heading into P3 nearly certainly doomed to failure.
The probability of success in adaptive P2/P3 Bayesian trials is difficult for the market (or anyone) to assess. This is perfectly suited to the speculative nature of ASX micro-caps and the retail market; what is even less understandable is always much better than what is perfectly transparent (from the point of view of speculative lifeblood).
The alternative scenario is a strong MBAci signal. NEU and the Retts organisation are having a big party this weekend. They thought it would be good form to invite the FDA folks along to take part in the festivities. To enable FDA staff to claim time off in lieu later this week they called it a “meeting”.
Trying to read the tea leaves on these things is a mugs game. Anyone more sensible than any of us wouldn’t say anything. Be interesting to see in a few days how silly or prophetic this far fetched theory looks.
(20min delay)