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marzan

01/02/21 11:55 AM

#344369 RE: CherryTree1 #344325

CT, Richard Pazdur approved so many oncology drugs bypassing the regular channel after his dear wife died of cancer. He knows the emergency need of a drug like DcVaxL that works, imo. AA or FT all are regulatory paths towards approval to make sure they do every check before they approve; and when they see OS5,6,7+ yrs >SOCs in multiples, Pazdur approves thru the Expedited Programs and review at his OHOP shop. See below how Gleevec got approved in 2.5 months. Ex thinks no matter how emergency the approval is, still has to go thru the regular channels otherwise in his mind the expedited approval other than Covid is as if is committing a crime; I think people have no ethics and morale when it comes to how they make money. I need Direct available ASAP. Will Pazdur give us?? I just heard my sister-in-law got uterine fibroid cancer scheduled for surgery Tuesday. I told them to save the tissues in case Pazdur approves Direct sooner as well in addition to DcVaxL. Ex and Lc et al are doing a huge disservice to the newcomers to this board.

https://www.fda.gov/drugs/news-events-human-drugs/our-perspective-expedited-oncology-drug-approvals

https://www.nytimes.com/2016/01/03/us/politics/fda-regulator-widowed-by-cancer-helps-speed-drug-approval.html

The review and approval of Gleevec occurred in approximately 2.5 months.


https://www.cancerresearch.org/immunotherapy/what-is-immunotherapy?gclid=Cj0KCQiA0MD_BRCTARIsADXoopb5ZpMuH0FaRpUFUOFuNmr2qO8HWGdULHw1WweaeJj2UBKz5BQU99UaAknPEALw_wcB