RE:RyplazimTM (plasminogen)PLI received a Complete Response Letter in March 2018 for Ryplazim from the FDA when they submitted BLA in 2017 which is material news but PLI withheld this news for a year until April 2019 just as they announced the restructuring for ultimate negative impact to the share price. PLI was unwise or negligent in not hiring outside expertise to assist in CMC of Ryplazim. 4 added checkpoints were needed in manufacturing process and they have apparently been completed based on Q3 conference call transcript saying the manufacturing costs have dropped due to not running any more runs but they have not specifically said that they have completed it with flying colours. They will amend the BLA and re-submit it in H1'20 after finishing paperwork around new CMC batch runs.
Longies123 wrote: I am so confused !!!!
Wasn't PLI at the last stages of getting RYPLAZIM approved from the FDA with just a few tweaks to manufacturing issues?????
Was it a total lie and disception from these horrible people.... to make us believe and to make us continue dumping our hard earned money in this company ????
And from what I heard on the presentation looks like they are asking for approval once again from the FDA for RyplazimTM (plasminogen).
Can someone explain ???
Tks