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clock Created with Sketch. 30/04/24
13:21
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Originally posted by nosluggos:
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Having read and reread todays announcement, I thought it would be worthwhile doing a comparison of the referenced interactions with the FDA , regarding previous similar announcements.April 30 2024 very pleased with the positive interactions having received clarity clear responses and guidance 26th March 2024 their collaborative approach. responses and guidance from FDA are clearand provide us with a high level of confidence 22nd March 2023 “We are pleased that the pre-license inspection of our manufacturing operations has been scheduled.We look forward to continuing to work closely with FDA 31 January 2023 maintained an active dialogue with FDA 23rd Nov 2022 been in regular contactwith the FDA over the past year 3rd Oct 2022 Mesoblast has maintained an active dialog with the FDA guided by FDA
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Totally agree with you, I have not seen Si/MSB this assertive and sure footed in there narrative in a long time.
(20min delay)