And if the answer is "Because the fda said no trial until we worked out the potency issues, etc", then why did Si pump this bla application and spout that he was confident it would be successful?
If he knew he couldn't do the trial the fda wanted because those issues weren't worked out, why submit? And why try and convince holders he had an iron clad resubmission?
It doesn't add up at all.
I'm not a holder so I've got no say. But I wouldn't touch this company while he is at the helm.
I'll bet he still gets his multimillion dollar salary tho.
Ann: Update on BLA for Graft Versus Host Disease, page-695
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