Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-1004

Now here's where you really go off the rails with "full of confounded questions that make no sense" and "baseles accusations". You don't really want to leave it up the the FDA, just to make sure you take the shot gun out and trigger both barrels. You actually want to offer a completely negative and extreme opinion about the content of the petition...

Not quite - I'm being factual, but yes the lassman law petition looks like it was written by a pre-schooler. Best you have a look at my post on the countdown thread.... the first confounded questions are Lassman comparing a disease severity grade Control response, to a non disease severity grade control response - as if the outcome has any significance whatsoever to Mesoblasts control arm rate. Which it doesn't. So yes.... the number of counfounding statements is vast, and false claims there are plenty of such as Mesoblast providing no new data. ( that made me laugh ), and Mesoblast submitting the BLA in October - ( another lie )
Plenty of them in there, it's a good fiction read that can easily trick the gullible into thinkng they were real problems.


An entirely reasonable post. Not sure of the relevance of the other letter to Mr Lassman.No obvious relationship to the Remestemcel BLA? Although in broad terms it does refer to the reasons for denying approval of a new drug according to the FDA's protocols regarding assesment of safety and efficacy.

Hahahahaha

Kind of like in the Lassman letter... I'm not sure of the relevance of comparing the control arm response rates, where 20% are Grade 3/4 with Macmillan trial, and 88% are grade 3/4 with Mesoblast trial. Talk about post hoc cherrypicking. Lassman must own a cherry farm, and a cherry picker with those sweeping broad categorical assumptions.