I think in the next 6 months we will be ticking off dollar markers and not just 10 cent markers as we have done in the past few weeks prior to any FDA approval.
Clearly the FDA are taking a new direction as supported with documentation to MSB and also links to the new strategy as posted here by those that are serious about science and are knowledgeable.
The distant memory of the 9 to 1 positive vote by OTAT will now look like a 999 to 1 positive vote as we approach again under a new regime of scrutiny.
I think in the next 6 months we will be ticking off dollar...
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