Share Price, page-12224

Hey MJC - I guess time will tell.

I would say a few things.

Firstly, I am not an expert but given the shorter duration of the trial compared to Retts, improved safety protocol and possible reduction in patient numbers than the Retts trial, we might see timeframes expedited. The fact that we are not taking this through to registration also reduces the timeframe somewhat. Whether that is to mid-2026 remains to be seen.

Secondly, there is plenty of evidence to show BP pulling the trigger before P3 results and plenty to show them waiting till after P3 results. My suspicion is that a BP may not want to wait until after a P3 trial and it is not a stretch to think that they could pay $15b prior to the results, given their balance sheets, the game changing potential of the NNZ 2591 pipeline and ongoing (and increasing) income from Daybue.

I don't want to speak for them but if I were part of the management team, I would feel like an "early" offer is a distinct possibility. If you think about it, if they believed that the P3 results won't materialise until at least mid-2026, why would they release the details of the other indications so soon? It makes no sense. There is no benefit to releasing that info, it would in fact be counter-productive, in that it gives competitors an insight into our timeframes and which indications to prioritise if they are playing in the same space. Why not wait to release the new indications until right after the P3 trial results, so that you get proof the drug works in a placebo-controlled setting and when the market is looking and paying attention, you let them know that the drug that replicates outstanding mouse results in human trials, has a whole range of new mouse trials that knock it out of the park - and the conclusion is that they will do the same in humans.

I think they know what the interest levels are and I think they know that adding additional indications is positive for them because they know the drug is safe, works and is applicable across a range of indications.

For what it's worth, I think the announcement yesterday threw a lot of people, myself included, but on further reflection, here is how I now read it and what I would have released if I were the CEO - or a version of sorts

"Following a highly productive meeting, the FDA has adopted the same approach it took with the highly successful trial for Trofinetide, the first neurodevelopmental drug approved by the FDA.

Mirroring the approach taken in the pivotal P3 trial for Trofinetide, the FDA has agreed to use a selection of the same endpoints in the P3 PMS trial, to those that were used in the hugely successful P2 trial. While a final decision on selected endpoints is anticipated by the end of the year, the familiar approach and strength of the P2 results across all endpoints, leaves the company in a strong position.

Additionally, the FDA has acknowledged the exceptional safety profile of NNZ 2591 by approving a less burdensome safety monitoring plan, significantly reducing the barrier to trial participation and expediting access to this life changing drug for patients."

The announcement yesterday did not say this explicitly but by inference it does and I suspect that the market might have missed it.