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Biotech / Medical : Regeneron Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?


To: A.J. Mullen who wrote (3348)8/2/2021 12:00:13 PM
From: CuttingEdge Bio  Read Replies (1) | Respond to of 3557
 
Try the company press release?
"In those who require repeat dosing for ongoing exposure, REGEN-COV can also now be administered monthly. This new indication in people aged 12 and older is in addition to the previously granted authorization to treat non-hospitalized patients. REGEN-COV is not a substitute for vaccination against COVID-19, and is not authorized for pre-exposure prophylaxis to prevent COVID-19."

Bold added for emphasis.

"Today's FDA decision to expand the use of REGEN-COV in post-exposure settings is a very helpful step, and we continue to work with the FDA as it undertakes its review of REGEN-COV in a broader group of people including in a pre-exposure prophylactic setting for people who are immunocompromised, and in patients hospitalized due to COVID-19."

Bold added again. I think what your link reflects is Regeneron PR-speak in which they are choosing to emphasize the positive - this helps them *start* to address the needs of the immunocompromised, at least in some restricted way. It does not allow them to truly address those needs fully, and they still have to get FDA sign-off on that in the future (in addition to the hospitalized Covid treatment EUA). What will the requirements be? Another trial? I look forward to the earnings Q&A.