Mesoblast in Freefall, page-652

@Sorepocket are you saying you know more than the 9 indepentent medical experts appointed by the FDA who stated on record that Remestemcel-L is an effective treatment? You havent posted any facts or references to back up the nonsence you post. Seems like you're getting a bit worried old darling hehe.

The market is jumping on MSB because they think that if the FDA can approve Biogen's treatment based on:

• little if any proven efficacy in trials;
• their own panel voting unanimously 10-0 against the treatment (as well as 1 undecided) and;
• biomarkers that have no proven clinical link to effectiveness or improved patient outcomes.

Then Mesoblast's Remestemcel-L which has:

• 3 trials/studies showing significant efficacy in pediatric patients
• ODAC panel voting 9-1 in suport of the treatment efficacy and
• biomarkers which have been verified by the medical community and linked to clinical/patient outcomes

now has a good shot at being approved when it rightly should have been approved last year.

My question to the FDA would be if you've simultaneously given Biogen approval and 9 years to prove that their drug really does work, then why can't you give Mesoblast approval using curent proposed manufacturing quality assurance measures and 9 years to come up with more refined manufacturing quality assurance measures that is to the FDA's liking? (Noting that there is no evidence that the current proposed measures are not sufficent).