Bruce Patterson : The FDA recommendation for a
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Posted On: 03/12/2020 11:50:59 AM
Bruce Patterson :
A meeting will give the opportunity to CYDY to incorporate more recent data. Not only the one already submitted but, rather, update FDA of what has been happening ever since.
If Dr. Patterson and Oncologists, Radiologists and MD's make a compelling case we will advance long way towards BTD. Not saying necessarily it will be granted right there but for sure FDA will have lots of info to achieve a speedy decision.
Very positive news in my opinion.
Quote:
The FDA recommendation for a meeting on CytoDyn’s BTD application is a tremendous opportunity to further discuss the mechanism of action and to summarize the promising results from patients enrolled following the submission of the application. Included in this discussion will be the recent decision by the oncologist of Patient #1 to, based on continued unremarkable changes to her condition, remove carboplatin from the patient’s regimen with continued therapy with leronlimab.
A meeting will give the opportunity to CYDY to incorporate more recent data. Not only the one already submitted but, rather, update FDA of what has been happening ever since.
If Dr. Patterson and Oncologists, Radiologists and MD's make a compelling case we will advance long way towards BTD. Not saying necessarily it will be granted right there but for sure FDA will have lots of info to achieve a speedy decision.
Very positive news in my opinion.
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