Allora io mi sono guardato la conferenza stampa e su un paio di punti sono stati chiari e non evasivi: 1) la discussione era praticamente finta e stavano davvero discurendo dell'etichetta (lable che immagino non sia quella sulla confezione, ma si intenda il bugiardin). 2) hanno confermato senza possibilità di smentita che hanno cash sufficente (oltre alla liena di credito aperta e basata sull'approvazione eroyalties sulle vebndite) per lanciare e vendere il prodotto (una volta che sarà approvato). Mia sensazione personale: secondo me FDA non si prenderà tutti i 90 per decidere...
$CTIC Key comments by CEO Adam Craig today:
“The FDA’s rationale for that, is the last information request that we sent in included some analysis of the data by very small cuts of the platelet counts. Not 0-50 as we typically do, but 0-10, 10-25. And they said they needed more time to analyze that data. We’ve looked at the data. We don’t think it’s a concern. We don’t think it’s going to change the labeling, in fact we think it hasn’t shown much. But the FDA needs more time. And the major amendment allows them to extend the PDUFA date.”
$CTIC “The other question we got asked, people are always concerned, is there a problem with your inspections, with your CMC when you have a PDUFA date extension. Absolutely not. We were inspected for chemistry. We were inspected as a company here in Seattle. And no 483’s were issued & all inspections are closed. So there’s no problem on the CMC or inspection side. It’s purely, we believe, the FDA needs more time to review. How long it takes we don’t know, but we do feel we are at the very last stages of the review process.”
