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Replies to #81021 on Biotech Values
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DewDiligence

07/17/09 9:10 PM

#81025 RE: mcbio #81021

TGRT:

There were 265 patients in the intent-to-treat number. The PR didn't break this down between patients receiving TC-5214 + citalopram versus those receiving placebo + citalopram.

From the documentation on clincialtrails.gov, I think we can infer that the randomization was 1:1.

If we split that number, you have 1 out of 132 patients, or 0.7%, in the active arm having a seizure. That is pretty much in line with the numbers for frequency of seizures in citalopram or placebo treated patients historically. So, I don't think this is necessarily bad news for TRGT's drug.

So far, so good.

Also, the seizure could be tied to citalopram and not TC-5214.

I would argue that assessing blame for the seizure is irrelevant to investors because the regimen being pursued in this program is the combination. Knowing which drug caused the seizure might be helpful to TRGT in determining the doses to take into phase-3, but it will be of no help to investors to hear that Celexa is responsible for the seizure.