Hi everyone. Firstly, congrats to all those who bought into NEU early. I dipped my toe in today after receiving the tip for a fellow poster on another forum. Unfortunately I held off buying until it nearly topped out this afternoon at $3.98 as I was a bit wary jumping in, but I'm in now
Geez, what a compelling story this is. It reminds me a lot of Clinuvel (CUV) of which I have a long held position dating back 13 years. Neuren was smart to let Acadia take trofinetide in the US to generate income to propel further development (probably didn't have much of a choice). But I hope Neuren is able to carry NNZ2591 all the way through to an FDA approval by themselves. Looking at the prevalence for the four diseases they wish to treat with NNZ2591, the potential is absolutely enormous. I would think it incredibly foolish to let NNZ2591 be licensed out to Acadia. Let's hope Neuren has the financial resources and regulatory nous to pull this off.
Their drugs are remarkable, and the potential for other neurological indications is considerable. One thing I noticed was repairing damage by reactive microglia. It's in the realm of possibility that these drugs could be used as an adjunctive to other Alzheimer's disease treatments. Regarding ROW, I think we'll see Neuren eventually partnering with a Chinese firm i.e Winhealth Pharma to introduce the drug into China. As they will have the Phase 3 data from the Lavender trial, once FDA approval is hopefully secured then Neuren should be able to go straight to the Chinese partner and seek a Named Patient Program route through the Boao Lecheng pilot zone on Hainan Island. This may only require a small cohort of 10 patients over a 3 month period. On average, from the time the NPP begins, drugs and medical devices following this route can receive approval for NMPA registration within a year. This process shaves months of the Chinese 'NDA' process. And regarding Europe, I don't see why Neuren cannot apply for an NDA with the trial data by themselves without a partner. The milestone payments coming over the next 24 months should be sufficient to build a small team staffing an office in Europe to handle the brief. They have to start thinking big and taking on the workload themselves regarding ROW distribution, organising manufacturing and other relevant matters. They are on the cusp of greatness here, just need to see Mr Pilcher take the leap and keep this company as independent as possible without relying on licensing partners. Its the only way to maximise value for management and shareholders. GLTAH
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