research reports and media, page-4222

So the FDA approval is most likely going to be pushed back 1 year, which is an extra $75mill+ of funding required.
It looks like absolute greed to me, when the company is on the brink of oblivion.

I would like to know, if they increase the trial to 404 days, can they still use the interim data at 56/128 days to apply for FDA approval then, or will they now need to wait for the 404 days of data. If they have to wait for 404 days of data, realistically FDA approval is at least 3 years away and it significantly increases all risks purely to possibly increase the reimbursement amount. I don't believe that great 404 day data will increase penetration very significantly.