Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-213

one of the smallest but its a biggie, MAY...
its hard to fathom after all those meeting we the FDA over the years it has not be sort, or advised by FDA before, exactly what they need etc, but them maybe it has and the FDA will again choose to change the agenda,
i hope MSB will get fed up with the FDA can take legal action against them, there are many Federal laws and guidance that can be used to say why, and why other things that aren't safe nor work, get approved. even the guidles of the FDA have the space for the approval process, yet as said also have the right unto themselve to change whatever they want.