"Biocon Limited (“Biocon”), our co-development and commercialization partner for axalimogene filolisbac in India and key emerging markets, filed a Marketing Authorization Application (“MAA”) for licensure of this immunotherapy in India. The companies will evaluate next steps regarding potential registration in India."
Are they referring to the previous filing or a new one?
I think, if the FDA is on-board with revamping of looking at interim data, Biocon could potentially reapply to the Indian FDA for approval.
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