RE:Consider effect of Right to Try bill in the US on PLII don't think they have the right to sell Ryplazim before the BLA. also, not many insurance cie would pay for a non approved drug even if it tested 100% positive. Think about it, managment said that with the new delay that will bring a new pdufa date in Q1 2019, they have the chance to submit the 48 weeks data for a full PGcd BLA. When ask about it by one of the 3 only persons who ask simple questions, the answer of Pierre was that a full BLA approval would help with the acceptance of the insurance cie to pay for Ryplazim so that sales will ramp up faster.
That's it. So since they cannot sell Ryplazim before a BLA and in any case the patient would have to pay a lot of money like 10 000$ per months, I dont think there will be any revenu from Pg before BLA approval in Q1 2019.
And this is if everything goes well. Prometic had the FDA hand in hand since 2016 when they filled the first BLA module for PG (thanks to the designation) so everything should have gone smooth and perfect and yet surprise! surprise!, 2 weeks prior the end of the PDUFA date, we learn that there is not a usual 3 months delay but an almost 1 year delay and worst of all, shorts looks like they knew it (maybe leaks or shorts might have influence over FDA???).
I know, people will say no no no there is no corruption at the FDA, it is a governmental thing and blablabla. I'm am not saying there is, but when there is so much money involve, I believe there is always a possibility. History showed that this kind of thing happen at every level of public administration, in every country in the world.
My point is, now PDUFA date is now in Q1 2019... for now. This time, I will believe it when they will receive it. And same for the PVR and IVIG.
For IaIp for NEC, I have no doubt they will get a PVR since there is a high mortality rate.
But that is in 3-4 years from now.
With Ryplazim for patient with PgCd, I don't know if the possibility are as high as this. But I most admit I don't know if there is or not mortality rate because of PgCd
I have lowered my expectations. time will tell
Eric