My question and answer from Fred - note in that in yellow Hi Fred,
Congrats on today’s announcement on Fibrinogen. Apparently we are going to need more than one NR in the near term to move the needle on the SP. This NR does raise some questions in my mind. Does the use of Fibrinogen require regulatory approval. Since I have not seen ant NR on that score, I assume that for now PLI does not have any such approval. are there two classes of use for Fibrinogen? One that requires a regulatory approval and another class of use that does not? If so how large a market does each such class of use represent? If this is not the case then there is only one unregulated market for Fibrinogen? This does not sound right. Could you please unconfuse me. Are we still planning to get some form of regulatory approval in the future to further increase our market reach for Fibrinogen?
Best Regards,
A confused
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The response from Fred:
Tks ........,
Just back in mtl this morning after 2 days of meetings in NY and Boston. Great set of meetings with top notch accounts in both cities. Very good feedback so far as well.
The sale of fibrinogen as a GMP product to be used by other pharma companies does not require any regulatory approval. If we do decide to also pursue on top of that some specific clinical indication then yes we will end up having to go through the same regulatory development pathway. I believe we eventually will but this is not what this announcement was about. It was simply to show that we will start selling GMP grade material extracted using the PPPS process from an operational plant while we continue our other clinical development programs (plasminogen, IVIG and AAT). This is just an additional revenue stream generation.
So yes there are 2 different scenarios here. Sales of GMP grade product to other pharma to be used in their manufacturing processes (does not require regulatory approval) and eventually the pursuit of specific clinical fibrinogen indication(s) that will then require a specific clinical and regulatory pathway.
Each class of markets are measured in hundreds of million. Fibrinogen is not 1 of the 2 yet to be disclosed orphan RX we have mentioned in our presentations. More to come on that front later on.
Tks
Best,
Fred
Frédéric Dumais, B. Comm., L.L.B.
Directeur, Communications et relations avec les investisseurs
Director, Communications and Investor relations
ProMetic Sciences de la Vie inc. / ProMetic Life Sciences Inc.
440, boul. Armand-Frappier, Bureau 300
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Tel.: 450-781-0115 (ext. 2234)
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