Friday, March 05, 2021 9:50:44 PM
this is a fantastic post, thank you for replying. I only made that comment based on someone else's conversation with DI today
As Flipper noted in a response to that poster:
”Nothing new. They made a strategic decision to publish results before releasing topline based on expert recommendations. This is to support the application for approval and to set a precedent moving forward.”
Why would DI say the experts are recommending a publication before TLD to "Support the application for approval". FDA does not need a publication and would probably 100% disregard any publication during their review.
I know you did not make these comments so I am not asking you to defend it. If this is in fact what DI stated then one would conclude that the BLA process has not yet begun.
Again thank you for the reply nonetheless, your contributions are top notch no doubt.
As Flipper noted in a response to that poster:
”Nothing new. They made a strategic decision to publish results before releasing topline based on expert recommendations. This is to support the application for approval and to set a precedent moving forward.”
Why would DI say the experts are recommending a publication before TLD to "Support the application for approval". FDA does not need a publication and would probably 100% disregard any publication during their review.
I know you did not make these comments so I am not asking you to defend it. If this is in fact what DI stated then one would conclude that the BLA process has not yet begun.
Again thank you for the reply nonetheless, your contributions are top notch no doubt.
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