RE:RE:if meeting with fda re pg and alstrom are positive sp will Pandorum stated, "FDA OKd pg..only condition is check points which are being implemented,"
Okay, it seems there is some confusion here on this issue, and I am not excluding myself as possibly confused. But here are some facts as I had understood them.
1. Plasminogen and sale of plasminogen are not exclusive to PLI. Other large pharmas produce it and sell it and have approval to do so.
2. PLI intends to sell Plasminogen too. No question there.
2. Ryplazim is PLI's patented orphan drug for the same indications as plasminogen. Nobody else has any right to it. No question there.
The question is this: are the new check point applicable to both Ryplazim and Plasminogen? If not, will addition check points be required on Ryplazim?
Next question: Is Ryplazim manufactured from Plasminogen or not. I understood that it was? This has some bearing on the check points in the manufacturing process.
Can anyone venture an answer?