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Msg  16885 of 16947  at  7/31/2020 4:58:06 PM  by

sphericalkutz


 In response to msg 16882 by  good_investor93
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Re: The FDA has changed its mind before on drug approvals & timelines

Good: This was a pretty poorly written article on this companies regulatory happenings by the author. A poor choice of words to use the term "rejected". Thats not what a Complete Response Letter (CRL) is at all!

When the FDA rejects your submission that means when you submitted it, the thing was not complete or organized to even bother reviewing it. But this company got a PDUFA date so the submission was complete at the beginning.

A CRL letter means the agency has reviewed your submission and they have found it "deficient" to approve the drug at this point. In this case it was over safety issues. The CRL letter then documents what the FDA expectations are for resolution. Often a company will then go and directly meet with the FDA to totally understand exactly what is needed in depth! the article makes it sound like suing the agency when the CRL process is formal in itself!

The company resolved those issues by either giving more pertinent data or by stimulating looking at the data in a different way and satisfied the agency issues.

The article says they resolved the deficiencies and they got approval after a short re-review. there are short/regular reviews and then short/regular re-reviews respectively by review time.

The FDA rarely rejects submissions unless the company involved is brain dead to the process or never communicated with the agency and these days thats rare. Given the condition studied, I am sure the FDA was accommodating as they could be.

the FDA can upgrade ACAD to a short review, but I am not holding my breath it will happen--never know? likely just approve it early instead.

JMO

kutz

JMO

kutz



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Replies
Msg # Subject Author Recs Date Posted
16886 Re: The FDA has changed its mind before on drug approvals & timelines good_investor93 2 8/1/2020 2:55:32 AM
16892 Re: The FDA has changed its mind before on drug approvals & timelines cm4cmc 1 8/2/2020 7:31:15 AM






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