NEU

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NEU is materially undervalued, page-18

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ashgood123

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11/08/24

09:58

Post #: 75156857
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Originally posted by Kryptonite: ↑

Couple of points:

Jon actually said between $50 and $100 million US for each trial (AUD$75-AUD$150m per trial).

if the US$250m sales threshold is achieved this quarter, the US$50 million milestone payment should be announced in early November. That’s another AUD$75 million in the coffer paid early in 2025.

As much as the EOP2 meeting will help inform the trial protocols for both PMS and PHS, Jon was emphatic that the meeting is about the former. As the PHS results came out about 6 months after PMs, does this mean that the commencement of any Phase 3 trial in PHS is going to be at least 6 months later than PMS? How much time can NEU shave off this? Is that even desirable and do they have the manpower. I must admit this is where I thought the muscle of BP could expedite things - I agree we have the funds but we are very lean (yes, I know most of it can be farmed out to third parties).

I went back through the timeline for Trofinetide in Retts Phase 3 trial and dug out the following:

The EOP2 meeting with the FDA was held around October 2017.
The plan for the Phase 3 trial was announced in Feb 2019
The Phase the trial actually commenced in October 2019
Enrolment was completed in August 2021***
Positive topline results were announced in December 2021
Acadia submitted the NDA to the FDA in July 2022
FDA accepted the Rett Syndrome NDA for Priority Review in September 2022
FDA approved Daybue in March 2023
Acadia launched Daybue in US in April 2023

***The Covid-19 pandemic led to a 3 month pause in trial enrolments between March-June 2020. More generally, did the pandemic slow done the trial? Acadia did very well in this regard imo.

Expand

Trofinetide in Retts Phase 3 trial is not really a benchmark. Neuren did not have the funds to progress phase 3 following the meeting with EOP2 and the agreement with ACADIA was only announced in Aug 2028 and took Acadia another 6 months to come up with the trial plan in Feb 2019

NEU Price at posting: $16.15 Sentiment: Buy Disclosure: Held
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