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.
Just a question
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Re: Just a question
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
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
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Re: Just a question
It probably can be prescribed but insurance coverage may be an issue.
Re: Just a question
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.
As bp says, anything can be prescribed off-label (half of prescriptions are), but it's useful to have approvals in more specific indications.
Re: Just a question
Does the FDA have to approve IMET unanimously for it to be approved after they submit their NDA?
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Re: Just a question
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.
Re: Just a question
Good information, thanks again, as always.
~ Kevin.
~ Kevin.