https://www.fda.gov/media/78941/download p.20:
Post# of 153875
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Posted On: 09/28/2020 3:23:22 PM
https://www.fda.gov/media/78941/download
p.20:
A RTF letter ends the review process and makes a resubmission necessary, starting the whole process again: BLA acceptance (60 days) -> RTF or acceptance -> Priority Review if granted (6 months). So, approval is about 8 months out after CYDY resubmits the application, which according to the annual report is planned by end of this year.
A good recent example for the process is BMY's ide-cel application that was initially rejected:
RTF letter in May; re-submission July 29; BLA acceptance September 22 with target date of March 27 (priority review)
https://news.bms.com/news/corporate-financial...fault.aspx
https://www.businesswire.com/news/home/202007...le-Myeloma
https://news.bms.com/news/corporate-financial...fault.aspx
p.20:
Quote:
A refusal-to-file decision ends the review process . The applicant’s options are to resubmit the NDA/BLA with the deficiencies addressed (the
resubmission is considered an original new application) or to request that the NDA/BLA be filed over protest
A RTF letter ends the review process and makes a resubmission necessary, starting the whole process again: BLA acceptance (60 days) -> RTF or acceptance -> Priority Review if granted (6 months). So, approval is about 8 months out after CYDY resubmits the application, which according to the annual report is planned by end of this year.
A good recent example for the process is BMY's ide-cel application that was initially rejected:
RTF letter in May; re-submission July 29; BLA acceptance September 22 with target date of March 27 (priority review)
https://news.bms.com/news/corporate-financial...fault.aspx
https://www.businesswire.com/news/home/202007...le-Myeloma
https://news.bms.com/news/corporate-financial...fault.aspx
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