RE:RE:BLAWhile we all knew this news was coming today, the filing of the Pg BLA is a major milestone for PLI and its PPPS platform. There is no doubt that the FDA will approve the BLA subsequent to which PLI will commence the production and marketing of its first plasma protein in Q4 this year.
The deficiency application of Pg is just the tip of the iceberg. Indeed, Pg can expect to become a blockbuster drug (sales over $1B/yr) as new applications for Pg are found in wound caring, acquired Pg deficiency and a myriad number of other applications in coming months/years. Moreover, PLI will be the world's only commercial scale manufacturer of Pg and we can expect the company to hold this position for many years down the road.
For those of us who have held this stock for 10+ years this is a major event. I look forward to early FDA approval, hopefully accompanied by a pediatric voucher. And then very importantly the filing of the BLA for IVIG (adult use) in Q4 this year:-).