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Tuesday, December 20, 2022 6:25:44 AM
Message in reply to:
Njce to hear from you Spideyboy and other patient PLX holders. From some questions I ask, here are a few interesting items I have learned very recently directly from Management: (1) Once 102 is filled and finished by Chiesi into (storage) vials, not infusion bags as I had assumed, its shelf life is 4 years. (2) Cheisi built a suite onto their fill and finish facilities in Italy for the production of 102. They already use this facility for another product they sell in the US, which may help ease the inspection process. (3) Unigal has been tossed around as the potential marketing name for PRX-102. The actual marketing name is still confidential and apparently will be released as approval moves forward in the near future. (4) Approval in Israel will likely tag along with approval from either the EMA or FDA. (5) They expect to start to fill Cheisi's pipeline in advance of approval which suggests first quarter 2023 sales to Cheisi. (6) Finally, there are two types of milestone payments: regulatory and commercial. The regulatory payments are received as approvals are received in various jurisdictions such as the EU and US, etc., etc. The commercial milestone receipts will follow at internals as the number of treated patients grows. In addition, we have the 15 to 40% royalties as the patient are treated, depending on rates in different jurisdictions and the number of patients treated.
2023 should be exciting for Fabry patients, management and shareholders. Will PRX-102 become the SOC? I believe so! Happy Holidays to all.
Happy holidays to you as well!!
Do your research! Play the TA. All posts are my opinion.
Is fundamental trading dead?
"We hope not." Richard Dennis
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