Biotech Values

[DewDiligence]

Thanks, Skep, for the Lehman report, but I find the report lacking in the way it ignores or brushes aside my pet peeves:

1. AGIX’s labeling the scan-reading as “blinded,” when the nature of the primary endpoint makes blinding an almost irrelevant consideration.

2. AGIX’s reporting meaningless p-values that were not calculated on an intent-to-treat basis.

3. AGIX’s unwillingness to disclose the precise criteria for discarding scans as “unreadable” (despite being asked on the CC) or the nature of the “technical difficulties” which necessitated the involvement of a second IVUS lab.

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I assume that Lehman’s report was published before Dr. Topol’s critique hit the presses. I’ll be curious to see if Lehman changes its tune in the event the stock tanks this week.

Until I hear some answers that make sense, my not-so-humble opinion is the phase-2b study should be scrapped. Given the excessive proportion of data points that were discarded, I think there’s only a minuscule chance that the FDA will accept this study as one of the two “adequate and well-controlled” trials required for product approval.

If it’s a given (or nearly a given) that a second phase-3 trial (one in addition to ARISE) will be needed for approval, why not start over, run a combined phase-2/3 trial with an SPA, and really do it right? Regards, Dew

P.S. I’m still interested in people’s forecasts for the share price this week. FWIW: I think it will be volatile and finish the week in the 20s, but I don’t have a heck of a lot of confidence in that prediction.