Hi Bazsa- not sure on your angle here?
Validated manufacturing process- Yes we have because no 483.
My understanding is there is a new improved and patented potency assay which required FDA sign off prior to commencing another trial.
But the assay I am referring to was in place during the Phase lll but not, until now- included in the submission.
Data from IL-2Ra provides clinical proof of potency - Testing with IL- 2Ra of current stock provides assurance of consistent potency. Moving forward there will be a more modern potency assay.
I'm just checking my version of reality- whilst sober
Reg
Cell Therapy News/Articles, page-17887
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