Replies to post #106068 on Biotech Values

[mcbio]

Re: CYP-1020 trial sites

One thing that bothered me with regards to the EAGLE trial was that only 2 sites were located in the US (see slide below). I asked the CEO at the time (Dr. Laster) and the reason he gave was as expected - cost. However, he also told me later that the data were similar in terms of response, efficacy and AE for different sites and historical data of Risperidone.

Thanks for the added cautionary color here genisi. For some reason, I thought the EAGLE trial involved a greater proportion of U.S. sites. Hopefully we can take Dr. Laster's comments at face value. Does the fact that almost half of the U.S. patients dropped out of the study concern you? Is that the norm for Risperidone? Also, no U.S. patients enrolled to extension, but I guess that was due to cost considerations.

[iwfal]

CYPB EAGLE Trial for BL-1020:

The largest enrollment occurred in India. Does anyone have any history/calibration of trials run in India? Certainly the Romanian portion is likely to be utterly worthless - but I do not have a calibration of India. And of course psychosis tends to be judged relatively subjectively and differ between countries - making the comparison/reliability more difficult still.

-----------------------------------------

As a recapture of your chart (which link will expire at some point):

US:

Randomized - 23
Withdrew - 11
Enrolled to Extension - 0

India:

Randomized - 252
Withdrew - 70
Enrolled to Extension - 61
Completed Extension - 34

Romania

Randomized - 88
Withdrew - 33
Enrolled to Extension - 14
Completed Extension - 11