RE:Ryplazim Partnership dealJan 2020 presentation page 6, they list items in chronological order; BLA submission, approval, Euro submission, partnership. Management made the same statement at the Stifel conference during their presentation.
Page 46 states commericalization and partner, SUBJECT TO APPROVAL.
"Late-stage plasma-based therapeutic, Ryplazim™ plasminogen, expected to be under priority review with PDUFA date in 2020
and expected to be commercialized in conjunction with global marketing partner,
subject to regulatory approval Page 48 lists partnership first, prior to BLA filing.
Agree company is providing confusing information.
or sah1 wrote: The wording of the PR has created confusion regarding the timing of the Ryplazim partnership deal. From previous corporate presentations the expectation had been created that it would occur before the refiling of the amended BLA not after approval by the FDA. The Jan 2020 corporate presentation also puts the partnership deal in advance of the refiling. Clearly the company has to clear the air on this matter.
Anticipated Key Milestones
1H-2020Expected commercial partnership for Ryplazim™
1H-2020Expected filing of amended BLA with FDA for Ryplazim™ (priority review expected