Well it sounds like DS are pretty confident. Timing is not a major concern, only less than 1 year before they submit for approval and the Japanese regulator will review on some sort of accelerated basis.
The question now is will the FDA allow the results to be used for emergency approval in the USA? They planned to carry out an emergency protocol assessment on Peramivir so there is a small chance they may do the same on LANI.
It going to be an interesting few months for Biota and the pipeline. I just hope HRV turned out ok, a poor result could hamper the share price in the short term.
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