The Field of Play for NEU through the eyes of Ken (AKA The Professor), page-28

Reply from Ken:

I'm sorry @hottod for not communicating more clearly. Earlier I said the following:

For commercial viability all a pharma needs is a base hit. I define a base hit for a NNZ2591 indication that provides a Trofinetide-level of efficacy. For this reason it won't matter to a pharma if indication "A" is less (or more) efficacious than indication "B".

This was in reference to a pharma who was considering licensing NNZ2591; not how well any single NNZ2591 indication would do in a competitive market.. When I mentioned indications "A" and "B" I was speaking about relative efficacy between 2 NNZ2591 indications. For example, the relative efficacy between Phelan Mcdermid syndrome (PMS) and Pitt Hopkins syndrome (PHS). I was trying to say that for a pharma considering licensing NNZ2591 it will not matter much if PMS has a better efficacy profile than PHS. Obviously in a competitive environment it matters greatly if any NNZ2591 "drug" is more or less efficacious than a competitor's. I was trying to address some of the nervousness that friends of my were having about the upcoming PHS trial results. I wrote the email for them but Mitch (microcapguru) thought it would be useful if he posted it on Hotcopper.

Also, with regards to the Inflation Reduction Act (IRA), as far as I understand it, this act applies only for Medicare pricing. The IRA's unclear language may have a negative effect on the development of orphan drugs. However, NEU's drugs target children and young adults. While Medicare is primarily for people over 65 years of age. And the IRA has no pricing impact on the Medicaid insurance programs run by individual states. Aside from private insurance I would guess that most patients will use the Medicaid program for insurance coverage. So it seems to me that the IRA will have a very limited impact on the value of NEU's IP. Also the Orphan Drug designation doesn't provide more protection than NEU's existing patent protection. So even without any Orphan Drug protection NEU (and by extension, whoever buys NEU) should be able to rely on patent protection to deal with competitive threats. Orphan drug designation primarily benefits drug developers whose patent protection may be running out shortly after getting marketing approval from the FDA.

BTW Hottod, I always look forward to reading your posts. A longtime admirer.

thanks, Ken