New valuation of PYC, page-9

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grimloq

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02/08/23

18:18

Post #: 69122296
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Originally posted by hottod: ↑

No TB, it won’t be that fast, even with fast track designation.

Neuren received fast track designation for trofinetide in Rett syndrome in 2013, shortly after commencing Phase 2. It also had priority review. It still took 10 years until FDA approval.

PYC can hopefully take considerably less time, subject to great clinical results. In the presentation in February this year, it is suggested that the Phase 1/2 trial will take 3 years – 1 year for Part 1 and 2 years for Part 2. Following that is the pivotal trial. Allow at least another 2 years. It then takes time to prepare an NDA (say, 6 months) and finally, a shortened FDA review takes another 6 months. So, allow 6 years to market, possibly 5 with other shortcuts like overlapped trials and rolling review.

An example of an antisense eye therapy which had speedy progress through clinical trials is ProQR’s sepofarsen in LCA. Patient dosing commenced in November 2017, there was an interim readout in September 2018 and the Phase 1/2 results were announced in October 2019. Meanwhile, ProQR had commenced a pivotal Phase 2/3 trial in April 2019 and results for that were released in February 2022. Had that trial been successful, ProQR might have received FDA approval by late 2022 or early 2023 that is, 5+ yrs from commencing in clinic.

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would accelerated approval allow sale of the treatment after Phase 2 (while phase 3 is continuing). Is it likely/possible in this case?

PYC Price at posting: 6.0¢ Sentiment: Hold Disclosure: Held
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New valuation of PYC, page-9

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