And combo will be approved , no question in my mind..

To reject drug one of those two things are needed , as I said many times in the past .

-- the most important , is safety , drugs with severe side effects , approval maybe questionable
-- second most important is efficacy..

We have great results in both ,

So if there will be a question about manufacturing , this may at worse delay for couple of months.
But we WILL be approved ...



IMO as always...