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kund

06/21/24 1:31 PM

#461973 RE: sage4 #461971

What's the point of Open-Label Extension?



It's a feel-good factor for management; they need some work to appear busy by following OLE sites with random questions. But the most important is their kick-the-can strategy. The longer the OLE, the better it is for them.
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Steady_T

06/21/24 5:23 PM

#462021 RE: sage4 #461971

OLE extension does three things. It allows those in the trial that were in the placebo arm to receive the trial drug is they so wish. It allows those on the drug to continue receiving it if they feel that it is doing them some good. And, it allows the company to gather information about longer term usage of the trial drug.

Given the high participation rate in the OLE that would suggest that the subjects think the drug was doing some good for them. The placebo subjects apparently seem to think that they want the opportunity to see if it will do them some good.