Thx TVThere are trial sites ready to go now. Naturally it will...

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rusty02

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28/08/23

08:27

Post #: 69577157
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Originally posted by thevinnys: ↑

Thanks, Rusty,

This Sleep Apnea Trial process is no doubt very clear and planned out in the minds of BC and the rest of the BOD.

I'd like to get a better understanding, knowing that there will be 40 sites / 400 patients. (10 patients approx per site?)
Do all the sites start with the same kick-off at phase 2 then after a period of time do the remaining sites that join the trial in say 9 months' time do they all start in phase 3 mode?

Understanding also that it is going to be an "iterative process", some adjustments may occur, depending on the preliminary analysis and the FDA feedback.

I will get a better understanding on Tuesday night.

Thanks @rusty02

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Thx TV
There are trial sites ready to go now. Naturally it will take time for all 42 site approval so maybe a phase in across all site. Bear in mind that trials are scheduled to start in November so some time still to finalise more sites and patent uptake. Yes there could/will be undoubtedly some twigging upon each interim feedback from the FDA the most important one is the 12th month. This is where approvals will be given to move the drug closer to full manufacture and commercise or more trials. I'm certain BC and team will be all over it. This was my understanding of discussions.
Look forward to your feedback TV.

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