You were all over the possibility of a BLA so your instinct is on. What do you think, is it curtains. It is a blow to see LeftYahoo's change in sentiment.
Was it you @@stocksa who wrote about BLA #2 lodged as an open approval, that perhaps it should have been lodged as an AA. A technical error in administration. We see that the response from the FDA was that a trial in adults is required. Perhaps this is in response to the open status of the BLA and not an outright rejection in SR AGHD for under 12s.
Is this not the most likely path forward. Relodge SR AGHD as an AA for under 12s. At the same time run the adult trial concurrently. Assuming they can get the funding needed to keep the lights on as well as run the trial.
CEO Itescu needs to go, page-41
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