You are correct. If memory serves, the Indian equivalent of the FDA wanted to see further clinical data. It may have been talked about on a call but has been mentioned here before.
Yes I saw that in one of the ADXS as I tried to dig back into this topic, but the language from the filing isn't really clear. The Indian FDA recommended that phase 3 data should be collected, but in the relapsed setting. And they didn't say no to approval in that case, either, so I'm not yet convinced.
Perhaps they were paid to wait until phase III. With the demonstrated significant efficacy and safety profile, one would think that Indian regulators would want to make the Advaxis treatment available to their population. However, they decided to wait seven more years before considering approval? Big Pharma likely has complete control of Indian regulators and the Biocon partners.
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