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Re: To infinity and beyond! post# 259719

Friday, 04/05/2019 8:45:21 AM

Friday, April 05, 2019 8:45:21 AM

Post# of 403047
This may provide some helpful info (underlines mine):

"Type B—Confidential between sponsor and the FDA. These include
pre-IND meetings, certain EOP1 meetings, EOP2, and pre-BLA
meetings. Type B meetings should be scheduled to occur within 60
days of receipt of the sponsor’s complete written request. Generally,
only one of each of the type B meetings for each potential
application will be granted."


There is plenty other good stuff about communications between FDA and sponsor in the article where the above came from. I recommend reading it:
https://stemcellsjournals.onlinelibrary.wiley.com/doi/pdf/10.5966/sctm.2012-0104

"I would rather have questions that can't be answered than answers that can't be questioned." Richard P. Feynman

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