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Posted On: 07/24/2023 2:52:53 PM
Post# of 148899
When I brought up SA as an asset, I meant it only as a deal maker. You are right, LL is our asset.
Let's see what FDA we get, I hope not the one that took away our EUA during the pandemic and put us into a long set of trials while LL was not kept in play.
I'm hoping for the Accelerated Approval pathway, under which the FDA may approve drugs for serious conditions where there is an unmet medical need and a drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients.
Let's see what FDA we get, I hope not the one that took away our EUA during the pandemic and put us into a long set of trials while LL was not kept in play.
I'm hoping for the Accelerated Approval pathway, under which the FDA may approve drugs for serious conditions where there is an unmet medical need and a drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients.
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