Re: A Special Meeting of Shareholders?
in response to
by
posted on
May 31, 2024 10:17AM
"How does that happen? - where you can't meet primary end points and pass any of your important trials, and yet the FDA and medical academic community is loving on your solutions to "rare air" levels with the BTD?? "
IMO, the end-points bar was set way, way too high by the FDA in BoM. ABL had to not only beat all 3 of the best standards of care in three separate indications, it had to beat all three SOCs by a margin of 30%! Falling short of this major improvement margin in just one of the three indications, no matter how incredibly safe it is, and you get from the FDA a flat out "Sorry, not useful, no approval of any kind, try again"? What?!?
Seems pretty unfair given that you see the FDA commonly approving near-poisons for non-inferiority, and in just one condition.
The question is: How did RVX not fight for some sort of conditional approval (with a Phase 4), or emergency approval? Especially after showing how safe the drug is, and especially after receiving the FDA's Breakthrough Therapy Designation? How does RVX not get the attention of big pharma with this obvious mega-blockbuster potential?
5 years of nothing, zero, cricket sounds from the office.
Is there anything about this leadership that doesn't smell to high heaven?!