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Re: SkyLimit2022 post# 560232

Tuesday, 01/17/2023 11:11:44 PM

Tuesday, January 17, 2023 11:11:44 PM

Post# of 820576
Ph3 trials are the trials that regulators require for approval considerations (others are only added value). Publication in a journal is an expected step with clinical trials, but they have no bearing on regulator's decision making. FDA takes ~12 months for their review processes and go much deeper in investigating the data and the trials than any peer-review process does. There are many trials that are published but fail to be approved by regulators.

You need to correct your statements -- the study manuscript was published in JAMA ONCOLOGY not JAMA. They are different publications.
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