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Re: SA article - Omeros: Competition Is In TroubleSleepyDog Some more context below. I love when people take the time to attempt to map out the steps ahead and the timelines. It keeps us all informed. But I think the conclusion you drew was off because of you misunderstanding of the FDA regulatory process. So would like to see a revised timeline again as it was slightly flawed, if you take in the realities of the FDA processes you mentioned. The 2002 amendments to PDUFA set a goal that a standard review of a new drug application be accomplished within a ten-month time frame. Have they taken longer? Yes, but the FDA guideline is to approve 90% of the applications within 10 mos. Gotlieb and his legacy have been shown make decisions even earlier than their PDUFA Dates, sometimes months earlier. Further if granted a Rolling Review, it means that a drug company can submit completed sections of the BLA or NDA for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review (a standard review, 10 mos) usually does not begin until the drug company has submitted the entire application to the FDA, so a rolling review significantly improves upon the approval process. Sections are reviewed as they are submitted. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track The following will help you understand the difference between Fast Track, Priority Review, and Accelerated Review Process https://resources.rhoworld.com/hs-fs/hub/161293/file-18168479-pdf/docs/accelerated_approvals_final.pdf OMS721 has both Breakthrough status as well as Orphan status. Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). However, I can't speak to what degree it does expedite the entire process (including development) Good luck . Revise your time line, share it with us. |
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Msg # | Subject | Author | Recs | Date Posted |
2748 | Re: SA article - Omeros: Competition Is In Trouble | sleepingdog | 0 | 12/11/2019 6:09:04 PM |