PAR

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23.5¢ paradigm biopharmaceuticals limited..

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12/04/22

21:43

Post #: 60817457
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Originally posted by Zenox: ↑

The impression I kept getting from the announcement was PR may be hinting that accelerated approval may be on the cards if our surrogate endpoints are in order. Relevant statements indirectly pertaining to accelerated approval were repeated far too frequently to be coincidental IMO, repeated time and time again "FDA Fast Track acknowledges osteoarthritis as a serious disease with an unmet need" - the two relevant criteria needed for accelerated approval.

Also from the link you provided:

https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track

A drug that receives Fast Track designation is eligible for some or all of the following:
More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed.

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Thanks @Denial and @Zenox. I really appreciate the effort you put into your comments, as well as Mozz of course.

Does any one know if other companies have our has had fast track status in the OA field? if so who and what's happened with them?
PAR Price at posting: $1.38 Sentiment: Buy Disclosure: Held
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