I was a strong supporter of AVX as many here probably know but when the FDA conditions for phase 3 were made known i sold out.
why?
well the current dosages were working fine and the 48 week data even confirms this but for reasons better known to themselves the FDA decided that the ATC dose would have to dramatically increased. The number of patients in the phase 3 would also have to increase substantially.
All this in a class of drug where there is already a mountain of data available.
The massive dosage increase in a much larger population increases the likelihood of encountering nasty side effects. I know the FDA gave some fuzzy reasons but i can't help thinking that perhaps there is a hidden agenda.
The recent excellent results are however leading me to believe that despite the increased dosages ATC may still make it through phase 3 unscathed.
Very tempting to get back in now.
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