Thanks DDWN.
I'm fine with raising funds as without it, the science means nothing.
It's the plan B and C, or lack thereof, that concern me too.
Prior to the first time Ryoncil was turned down by the FDA, the ADCOM voted 9 to 1 in favour of it. We then got the nasty surprise that the 9 to 1 vote carried no weight with the FDA, and thumbs down from them.
The second time SI submitted it for approval, they got another thumbs down from the FDA. While I believed that they had every right to be confident with their second submission, the first submission result should have made them anticipate the small possibility of another thumbs down from the FDA, and as such they should have had a plan B. I was gobsmacked that SI did not have a plan B - he just looked green in the gills at the no decision.
This time around I hope he is seriously considering the, I think small, possibility that Ryoncil for kids may get another thumbs down. This new financing transaction needs to cover that possibility. We can't hedge against everything, but some prudence should be applied given MSB's history with the FDA.
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