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8.9¢ percheron therapeutics limited

Sarepta FDA Hearing, page-65

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monti901

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17/05/23

11:12

Post #: 67817517
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Originally posted by dalts66: ↑

ODD will give 7/10yrs (eu/usa) sales protection after drug approval.
Fast track drug approval will allow the drug to be approved after a phase 1b/2b trial, with the requirement that an expansion trial is undertaken to provide more data. Drug sales allowed early on.
To fast track you need to be addressing rare disease with no SOC.
Rare pediatric disease may allow Breakthrough Drug Designation, which helps expedite the drug development and approval.

But we need the drug hitting arms and the trial underway before any of this happens. Hopefully last half of June for that so the 6 month human dosing aligns with the 9 month tox study.

Once drug approval for DMD is given (hopefully achieved), rolling it out to other indications with the same biomarkers becomes much easier as well. So transition to platform drug is also a real possibility.

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Lots of news coming over the next few weeks. I am really surprised that the funds are not buying up at these low prices.. hopefully a shift in sentiment for the bio sector should see us in the box seat for a rerate soon.. GLTA

ANP Price at posting: 7.0¢ Sentiment: Buy Disclosure: Held
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