Very interested to hear the outcome the BoD has decided. It's...

Very interested to hear the outcome the BoD has decided. It's been a long time coming.

Here's my thoughts for any of our regular contributors wondering.

Given that PMD secondary outcome is out, the US FDA is unlikely to consider this to be a pivotal trial. I expect a redesigned trial will be for registration in the EU with a 1 billion TAM. If the market assessment shows that the TAM will be largely eroded by the obesity drugs in the coming years, then my preference would be that it's appropriate to abandon the IIH program and pivot early to a new indication.

Moving forward, the lowest hanging fruit is a phase II in Traumatic Brain Injury(TBI) as was briefly mentioned in the recent Annual Report. Both a phase II trial in TBI and redesigned Phase III in IIH will require several months lead in time, but the benefit of TBI Phase II is that our TAM isn't going to be eroded. The other benefit is that a Phase II is much faster and hopefully will have some results in a quicker timeframe than a redesigned Phase III which will boost our share price. From there, things will get interesting since the Board can partner the drug to approval like Neuren, cap raise into Phase III or sell to pharma who will be circling given the lack of effective drugs in this indication.

Other options are possible, but I think it's unlikely that the board will wind up the company and return cash to shareholders, turn it into a shell or try selling the IP. The drug works and has been published in peer reviewed journals. It's rare in biotech to find something that works and I suspect the Board won't want to let this go until they've exhausted all options given its commercial potential.

The main sticking point is whether the Board can provide an incentive package to keep Prof Alexandra Sinclair around for the Phase II TBI Trial. No doubt she will be incredibly disappointed that her life's work in IIH will not see a drug approval. However, the rapid uptake of GLP-1 drugs for obesity was outside of her hands and like everyone, was caught off guard with the ferocity of its uptake. Nevertheless, her brilliance in finding this mechanism of action should not be in vain, and given the opportunities of other conditions that this drug could treat, it would be a shame for the Board to lose her.

All of this ultimately hinges on the result of the market assessment. Good luck to all shareholders for Tuesday.