RE:Complete responsePLITheOne wrote: I believe that I had brought forth the conversation with posting PLI in reciept of a Complete Response letter from the FAA. I tried to find my original post and attach but can't seem to navigate to page 2 of my posts for some reason.
I just want to be sure if anyone accually found the statement where this was revealled?
I haven't specifically found or searched for it myself, but I recall hearing it, it could be from the slides or call. If the sourse is mine, could be, we need to find that statement.
Has someone else also heard this and can confirmed that it is accuratly recorded somewhere?
Thanks
PLITheOne
I went through all the PRs and MD&A on sedar.com from March 2018 to April 2019
April 1, 2019 is the FIRST and ONLY time that the receipt of CRL complete response letter is disclosed.
On the page 6 of April 1 2019 PR
April 1, 2019 PR "Plasma-Derived Therapeutics Segment Key Events for 2018: RyplazimTM – Received a Complete Response Letter (“CRL”) from the FDA arising from its review of the RyplazimTM BLA."
On the page 8 of April 1 2019 MD&A
April 1, 2019 MD&A "Ryplazim™ for the treatment of congenital plasminogen deficiency is the first biopharmaceutical expected to be launched commercially pending the review and approval of the amendments to its BLA required by the FDA following receipt of a Complete Response Letter,
in April 2018, to the original BLA. The corporation expects to file the BLA amendment in H2 2019."
So it would seem that the company has received the CRL in April 2018, but only disclose this material news for the first time in April 1, 2019.