RE:RE:Timelines clearly defined and confirmed last cc:I have had buffoon on ignore for years because of his insane pumping of PLI and had to log out to see what Newstupsjohnsonpando was thanking him for. I see he has returned after scurrying away when TV crushed the SH and the first BLA crashed. I have added my comments within SB post. "I see you love to act superior and try to beat people up instead of having a normal discourse of ideas and facts. Pando group have made so many dumb comments, predictions and called posters liars and proven WRONG so often, its not hard to look superior to him. Also, funny to see you lecture him right after he thanked you. Who is acting superior in that post I don't see a change/ delay to what liminal committed during Q2'19 call on Ryplazim BLA submission in H12020? Straight from transcript on seeking alpha "continuing to manufacture in related activities to enable a filing of an amendment to our BLA, with the FDA in the first half of 2020, seeking marketing approval for Ryplazim in the United States" I never said it was a change/delay in the schedule. Was asking why after seven months it isn't completed. They hired experts after the first BLA crashed to assist them with the BLA . Pando group of IDs has been saying for many months once new controls are in the BLA will be filed quickly and approved in two months by FDA. His predictions, not mine.
They are not simply filling out a few forms. That's a misleading statement on your part. Pando group of IDs have stated numerous times that once the process changes are made (Sept 2019) resubmission is basically a formality. So far, a seven month formality.
It sounds like you know what they have been doing for seven months. Enlighten those who care to follow you with what they have been up to.
They still have 3 months to meet their timeline.
CEO Galbraith then says in Q2'19, CC Q&A. "And if that takes a little bit longer then that is the right thing to do for shareholders."
That sounds pretty smart to me instead of rushing something to the goal line at this point after paying high paid CMC consultants a lot of money. There is a lot of interaction between FDA and Liminal after the manufacturing and fill & finish is complete and compiled. I am expecting them to file anytime now and partnership will happen very soon as marketing activities would happen as BLA is getting PDUFA date (dramatically shortened as BLA went through previously) and then going through final approval in 2021. You have been making rosey predictions for about four years that I know of and I put you on ignore . Hope I didn't hurt your sensitivities.
GunnerG wrote: Seven months since FDA additional processes completed (Q3 Sept 2019). What could possibly take seven months to fill out a couple of forms and submit to FDA.
Obviously there is something else that has happened to stop Ryplazim in its tracks. Seven months and you clowns aren't questioning what has happened to put the brakes on this once
again. Newcamo wrote: FDA already reviewed riplazym and passed conditional on check points being set. They are set, resubmission is basically a formality:In early 2019 the Company established the following critical path towards regulatory approval for RyplazimTM in the U.S. is as follows: