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.
In my opinion, there is an order of magnitude of difference in the positivity and warmth (SI is far more effusive) compared to the previous announcements relating to BLA resubmission (see below extracts form previous company announcements ... spot the difference).
Apparently according to my family this "warmth & positivity" is being reflected in me today (I paid for my sons car insurance).
April 30 2024
Mesoblast Chief Executive Silviu Itescu said: “We are very pleased with the positive interactionswe hadlast quarter with the FDA, having received clarity on the path to licensure“Based on the clear responsesand guidance from FDA we intend this quarter to resubmit our BiologicsLicense Application (BLA) for approval"
26th March 2024
“We thank the agency for their collaborative approach. The responses and guidance from FDA are clearand provide us with a high level of confidence to refile our BLA
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 during the review period.
31 January 2023
Mesoblast has maintained an active dialogue with FDA since receiving the CRL and in October 2022 .
23rd Nov 2022
Chairmans addresss AGM
In addition to preparing for the remestemcel-L BLA resubmission, we have been in regular contactwith the FDA over the past year across our broad portfolio of products
3rd Oct 2022
Mesoblast has maintained an active dialog with the FDA since receiving the CRL, and the substantialnew information submitted to the Investigational New Drug (IND) file for remestemcel-L in the treatmentof children with SR-aGVHD, as guided by FDA.
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