I think their actions lean more toward launch mode. Particularly with the Ms. Jenkins hire right on April 30 (day 153 from Nov 28 chm). Personally, I think they are discussing (ironing out) details/strings or no strings not new RFIs. Why bring her on if we just received yet another RFI?
(My AI seems to believe she is a launch specialist)
Now, April 21, we are preparing our own Leuk clinic for future demand. The buildout itself completes in June. That timeline would be a bold lie if it were not true. GZ states it doesn’t even have to be built or licensed before any approval.
We are three weeks post day 153 and three weeks post Ms. Jenkin’s hire.
If there is no news by the end of this month, it becomes quite likely that either the application is going through an appeal or the best case scenario is an approval with major conditions and therefore narrow scope. You can certainly throw NICE reimbursement out of the window for the next 2 years.
Expect all time lows this summer if there is no news this month. But hey great opportunity to average down, LOL! ;)
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