Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-274

Ultimately, there is only one side that has the advantage of studying, preparing, designing the trials and subsequent data for the last 10+ years. Only one side that has thought through every single argument for and against. Only one side that knows exactly what the Regulator wanted to see in the trial design and subsequently spent investor funds to meet those requirements.

A $300K consulting job from Lassman is not going to be a match on the science and understanding all the intricacies of this submission.

Make no mistake, this is not about stopping the approval per se. It is about protecting a competitor's market and getting on record FDA justification on their decisions which will ultimately be used to try and limit Ryoncil's indication and labelling. They are playing the long game and want enough objections recorded to slow Ryoncil's future expanded indication plans which will impact Jakafi's space.