Well the big catalyst will be FDA approval ...my guess 80-85% probability of approval on/ by June 28th ( assuming no FDA inspection delays in India ) ...followed by filing for TDAPA by July 1st . Regarding revenue . There is from my limited sample ...growing frustration with the dialysis bundle as it cedes to much power to the for profit / private dialysis providers ( they dominate the US market )
" Why even have an MD involved when the insurers or dialysis providers dictate want pho binder my patient gets ".....common attitude I've found recently.
I had been making the case at recent dialysis clinic staff functions on how OLC would be 100% covered by Medicare in 2027 ( assuming approval ) ...so free to their patients for at least 2 yrs. The RN's bought into that . The MD's had more of a " Nice but "...attitude .
The BUT part that they didn't really want to talk much about is the problems they have just getting the pho binders they want to prescribe . They are available but the major dialysis providers force prescribers to justify why their patient can't have Renvela ......and write a report on each individual patient . Huge prior approval hurdle . This is going to be a major challenge for our Ceo ...negotiating with these Co's following approval . They seem to be the gate keepers on who gets what for serum pho lowering . So hopefully our Ceo can use his investment banker experience to negotiate us a great deal :--)
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