Re: Take Home Points: not ready for use in patients
in response to
by
posted on
Nov 16, 2019 04:06PM
I think you are looking at it the wrong way. It is not Dr Shah whose opinion matters...it is the FDA and Big Pharma.
Now that the data is out, it becomes a question of who steps up to buy up RVX. The check will totally depend on what the FDA's letter in mid December is going to tell RVX. The very low probability is immediate approval for CKD. The most likely scenario is a Big Bolt On Study. That is at least my base case.
Is there enough for a Big Pharma to write a check? I will be totally shocked if BP is not impressed with this kind of data.
Low eGFR patients seeing a statistical improvement in kidney function? Who ever heard of that? 18% to 21% lowering of RRR in such a sick population? No safety issues, beyond the usual blood test to make sure your liver is not temporarily damaged? Potential for more indications down the line?
Any BP must be basking in happiness that RVX did not succeed too much...the smaller check they need to write is acceptable to any board of BP...not to mention excellent the future career of any business development officer who will repeatedly take credit to climb corporate ladders years into the future!