All negatives aside with respect to pipeline delays, the fact is that we could be profitable in 2 years if TT-034 works. If later cohort participants are cured, a relatively cheap PIIb (or extension of the current PI/II) with 50-100 participants could be all that is required under the FDA's breakthrough therapy designation. A one-shot cure, without interferon, ribavirin, and minimal side-effects for HCV is just the sort of drug the FDA is looking for. Wouldn't that be too bad for Gilead who think they have it all stitched up with their 12-week program (with interferon) for genotype 1 (70% of patients). How many patients, or their doctors, would prescribe a drug that has to be taken in conjuction with interferon that has horrendous side effects if there is a safer alternative that can be given then and there and the treatment is over.
The timing of the announcement regarding plans for the NSCLC program suggests this exercise was really all about having something to fall back on if the RAC didn't react favorable to TT-034. If PI/II shows promise, we need to preserve all our capital to get it to market asap.
Call me greedy, but I don't want to share TT-034 with a BigPharma co. to take all the glory and half the profits. Stuff-em!
http://medcitynews.com/2013/07/drugmakers-love-the-fdas-speedier-breakthrough-therapy-designation-but-theres-a-challenge-to-get-others-on-board/
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