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Re: 12x post# 467125

Sunday, 08/11/2024 12:02:40 AM

Sunday, August 11, 2024 12:02:40 AM

Post# of 519039
Exactly!

Truly lame to say the open label small P2a trial confirmed anything. In fact it is completely opposite that the larger P2b/3 trial did not confirm dose and other findings from the P2a trial, which had a crossover design for 5 weeks where all patients were switched between 10, 20, 30 and 50mg.

The final crossover dose cohorts then finished on their respective 10, 20, 30 and 50mg doses at least for the duration of the part B without extensions. After that who knows what doses were given and from which some dropped out.

There were about 10 patients left the last time the AU cat B compassionate patients were mentioned.

We now eagerly await how the P2b/3 vs. P2a peer reviewed deep subgroup analysis pans out and how much is in fact confirmed. Even more eagerly we wait to see if an MAA is in fact filed and accepted.

If an MAA is accepted we wait to see if it will pass clock-stop 1 and then if some form of conditional approval is given - because at least I have trouble believing that a full approval is very likely.

The longer we wait, the sooner we will get rich!

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