Intra-Cellular Therapies: It's Not Time To Give Up On This Biotech

•Shares are down 65% in the past six months, but if discussions with the FDA go well management could submit an NDA and shares could rebound in the near term.

•While lead asset lumateperone flunked a phase three study, the 60mg dose did improve schizophrenia symptoms in all three trials.

•High placebo response can problematic in similar types of trials, but the FDA could take into account the totality of data from all three studies plus the differentiated safety profile.

•Some well known institutional biotech investors hold positions, updates from other late stage studies could provide upside in the medium term, and cash position provides downside support.

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I thought this was interesting. If at first you don’t succeed, try, try again.

Risks to this story include the already mentioned FDA downthumb, resulting in the company needing to run additional studies and burn through more cash. Also, investors should be keeping a close eye on how enrollment for the other phase three programs is going. Primary completion is in October, representing another material catalyst.

I think they need to try different doses for the trials, for some drugs you need very specific doses to get the proper effect. Not just 60, 80, 120. Maybe at like 123.579 you will get the desired effect.

This medicine has/had the potential to revolutionize treatment for our disorders. I certainly hope it works if it does get approved. There have been some meds that were approved that simply do not work either. Geodon is one of those in my opinion.

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