Just a question

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KTArsenal
Posts: 103
Joined: Fri Jul 01, 2022 10:35 am

Just a question

Post by KTArsenal » Tue Jul 05, 2022 9:51 pm

Ok, so Geron is going after other indications through PI CTs.

If they get approved for MDS, does the FDA require that all phases be completed before another indication is approved, if the approved indication is basically relative to the 1st approval?

I've Googled a bit and can't find any solid answers to this question. Thanks in advance,
Kevin.

kmall
Posts: 753
Joined: Thu Mar 21, 2019 3:57 pm

Re: Just a question

Post by kmall » Wed Jul 06, 2022 5:05 am

Far from an expert, but I believe perhaps this is the answer to your question: Off-Label

Off-Label: relating to the prescription of a drug for a condition other than that for which it has been officially approved.

https://www.fda.gov/patients/learn-abou ... rugs-label

Please feel free to correct if I'm off base here. -Kmall

biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

Re: Just a question

Post by biopearl123 » Wed Jul 06, 2022 5:42 am

It probably can be prescribed but insurance coverage may be an issue.

cheng_ho
Posts: 202
Joined: Sun Apr 03, 2016 11:27 pm

Re: Just a question

Post by cheng_ho » Thu Jul 07, 2022 4:38 am

My understanding is that they shouldn't have to do a Phase 1, since Imetelstat has repeatedly been studied for safety.

As bp says, anything can be prescribed off-label (half of prescriptions are), but it's useful to have approvals in more specific indications.

KTArsenal
Posts: 103
Joined: Fri Jul 01, 2022 10:35 am

Re: Just a question

Post by KTArsenal » Sun Jul 10, 2022 6:44 pm

Does the FDA have to approve IMET unanimously for it to be approved after they submit their NDA?

biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

Re: Just a question

Post by biopearl123 » Sun Jul 10, 2022 8:18 pm

My understanding is that part of the approval process is review by a board of experts. This board makes a recommendation to the FDA which may or may not be unanimous. The FDA usually follows this recommendation.

KTArsenal
Posts: 103
Joined: Fri Jul 01, 2022 10:35 am

Re: Just a question

Post by KTArsenal » Sun Jul 10, 2022 8:36 pm

Good information, thanks again, as always.

~ Kevin.

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