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Steady_T

02/01/22 2:00 AM

#347624 RE: end2war #347622

I think it is a safe bet that the reclassification came after discussion and approval of the regulators. The same is true of the changes in endpoints.

You are correct in the OLE providing longer term safety data as well as a look at efficacy over a longer time frame.
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boi568

02/01/22 2:04 AM

#347625 RE: end2war #347622

Keep in mind when discussing the value of an OLE that 2-73 has very little left to prove regarding safety.