Hi @dachopper,
Yes I agree we are stuck in this ridiculousness position.
Silviu told me in the presents of a few others after the recent AGM the "Company focus and objective was getting Ryoncil (remestemcel-L) FDA approved first.
Dr Krause who joined our Board back in June last year was formerly Deputy Director of the office of vaccines research and reviews at the FDA and internationally recognized on development and regulatory aspects of biologics products, what a coup for Mesoblast, l believe his appointment is the key and with many FDA past decision makers "moved-on" to pursue other interests !! his experience and relationships within the FDA bureaucracy will guide our products thru the hoops and provide the "saving of the FDA face" after that ODAC submission debacle, plus l recall just after that knock-back our CEO then said "the FDA had previously said they don't want to have unregistered use of Stem cells, they are not opening up a Pandora's box" well that's now in the rear-view mirror, hence my view Dr Philip Krause is the Key !!
ST
Hi @dachopper,Yes I agree we are stuck in this ridiculousness...
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