Whytee I agree that there are risks here, but there is a very strong likelihood that MSB will have its first approval on 2 August if not earlier. The risk/reward calculus is compelling.
It was back in March that you stated that, after doing a lot of research, you had come to the view that a conditional approval would most likely be granted, meaning that approval would be granted on condition that there would need to be another trial in adults or adults and children. I don't know whether the approval will be conditional, but I honestly can't see the FDA insisting on a further trial in young children. We will see.
Many here understand that there will need to be another trial in adults. This suits MSB longer term strategy because it will facilitate label extension into adults if successful. Approval will make the funding & recruitment for the new trial that much easier.
So, just to put all your negativity into proper context, you nonetheless believe Ryoncil will be approved for children in sraGvHD? Or has your opinion changed and, if so, why?
MSB Price at posting:
$1.15 Sentiment: Buy Disclosure: Held
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