Biotech Values

[DewDiligence]

Re: HCV combination studies

>I would think this would not be an insurmountable target for some combination of Protease/polymerase with SOC and wonder why it is not pursued more?<

There was a long thread on this subject about a year ago, IIRC.

Several antiviral companies give lip service to running trials with two or more unapproved drugs, but when push comes to shove they don’t want to do it. Companies are rightly afraid that a safety problem caused by another company’s drug will stain all of the drugs in the cocktail and thereby derail the development plan of their own drug.

The FDA too has given lip service to running such combination studies, but it hasn’t done squat to make the idea more palatable in practice. You can cite this as yet another case where the FDA has failed to provide the leadership to help newer and better drugs get to market.