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Targacept Trial Tragedy Takeaway: Don't Trust Clinical Data From India

WINSTON-SALEM, NC ( TheStreet) -- The lesson from Tuesday's Targacept (TRGT - Get Report) TC-5214 tragedy: Never trust clinical data from India.

I repeat: Never trust clinical data from India.

Clinical trials conducted in Russia aren't any more credible, so don't trust data from there either.

I should have had this lesson permanently seared into my brain after making a bad call on Medivation (MDVN - Get Report) and its Alzheimer's drug (clinical data from Russia.) But stupid me, I blew it again by predicting success for Targacept and its anti-depressant TC-5214 (clinical data from India.)

Any hope that something positive could be salvaged from the failed TC-5214 phase III study were pretty much dashed this morning when Targacept's CEO, speaking on a conference call, said '5214's effect didn't separate at all from placebo.

If '5214 didn't perform any better than a placebo in alleviating symptoms of depression in this phase III study, the chance that the drug performs any better in the remaining three phase III studies is really low.

And that also means the spectacular data generated from the phase IIb study of TC-5214, conducted largely in India, were a mirage.

It's difficult to reach any other conclusion although Targacept on Tuesday's call insisted that the phase IIb study was conducted with diligence and that its partner AztraZeneca (AZN - Get Report) did a lot of confirmatory work before agreeing to license TC-5214 for blockbuster terms.

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AZN $71.55 0.00%
BIOD $1.08 0.00%
LLY $72.41 0.00%
MDVN $127.22 0.00%
TRGT $2.35 0.00%


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