While it is still early in Dr. Tidmarsh's tenure as CDER director (appointed July 2025), several changes to accelerate drug approval have already been implemented or are being considered by the FDA leadership:
I still expect a Class 2 re submission but a Class 1 is not totally out....maybe 30% chance WAG
Re being having to endure etc . I look at this as waiting patiently ( hard to do I know ) ) for what may become an excellent buying opportunity . That being when / if the Co announces a small capital raise after getting a Class 2 resubmission notice . IF the stock ends up on the day of this capital raise ( if it happens ) ...that for me is an excellent buy signal ...reminiscent of my experience with Myocardia ( MYOK ) now bt out.
As you know ...I'm a big believer in OLC seeing a rapid uptake once its in the dialysis clinics ( which has been a problem with Velphoro ) ...and possibly dominating in 2027 as being the only new pho binder to still have 100% Medicare reimbursement. . If approval is delayed ( not denied ) ...it gives the Co more time to get OLC in front of Nephrologists ...note recent Journal article .....and more time for the clinics to get fully up to speed storing and dispensing the pho meds .
Meanwhile theres action elsewhere ...chk my "boards posted on " if you want to see where I and some others here are active . Good luck Kiwi