NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Hi flipper / senti

Just curious if you have read the correspondence between Novartis and the FDA with regard to Piqray, which received approval through the RTOR process? It appears to me that when Novartis met with the FDA for their pre-NDA meeting to discuss their submission on October 16th (after submitting their data and analysis, which confirmed the trial met its primary endpoint), at that time, Novartis was simply requesting “priority review.” It is unclear though who suggested using the RTOR process, it just says:

“Meeting Discussion: The FDA and the sponsor agreed to conduct the review using the Assessment Aid and the Real Time Oncology Review (RTOR) pilots. The FDA agreed to standing bi-weekly teleconferences with the sponsor, which can be canceled if there no issues requiring discussion. For the CMC section, a decision on standing teleconferences or an extended face to face meeting will be decided once the CMC section is received. If the sponsor has updates to the original submission, they will not replace the original documents, instead they will submit an updated document with tracked changes, summary of changes, and final version. FDA will base their review on the originally submitted documents unless instructed otherwise by the sponsor. The table above represents the agreed upon timeline for submission of components of the application. “


My observation just looking at the correspondence though, it appears that Novartis had a pretty straight-forward IND and NDA in a nice neat package that was ready-made for this type of approval process. (and Charlene Wheeler was involved throughout)


https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212526Orig1s000AdminCorres.pdf