Replies to post #3921 on Biotech Values

[rkrw]

Seems there must be more to the Topol/AGIX story. His actions are the top and strange, even slander. A friend of mine wonders how agix can have CC do the rest of the ivus analysis?

I still bet agix gets acquired or has a MAJOR jv well before the arise data are in.

Here's some news on epix, agix isn't the only one with unreadable scans :-)

FDA Extends New Drug Application -- NDA -- Action Date for EPIX's MS-325 to mid-January 2005

The extension stems from recent submissions, at the FDA's request, of additional analyses of previously submitted data. One of these submissions has been classified by the Agency as a major amendment that extends the FDA action date. EPIX's post-application submissions include several analyses relating to non-contrast MR imaging, uninterpretable scans, and subgroup analyses by scanner type, geographic location, vessel bed and readers. FDA regulations provide for a three-month extension period, which would result in a revised FDA action date deadline of mid-January 2005. The extension notification by the FDA did not include a request for any new data.

[DewDiligence]

More musings on AGIX:

>> I believe AGIX has a SPA for the ARISE trial and so, if it meets its endpoints, the FDA will most likely approve it on its own merits and NOT require a confirmatory pivotal trial. <<

I was talking about this with ‘poorgradstudent’ last night. By suggesting that no confirmatory trial will be needed if the results from ARISE are positive, AGIX is essentially treating the existing phase-2b trial (the one causing all the fuss) as a quasi-pivotal trial. Yet the phase-2b trial, even if all the patients had been evaluable, is very small for a pivotal or even a quasi-pivotal trial in cardiology.

I would like to see the contents of AGIX’s SPA to see if it says that AGI-1067 is actually approvable upon a positive outcome, or if it merely says that ARISE can serve as one of the two pivotals if the results are positive. The company has been intimating that it’s the former, but I wonder if they are telling the whole truth.

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One final observation on the phase-2b trial: AGIX could probably have withstood any criticism of the trial design and conduct if they had required the scan readers to read only a single scan at a time rather than a before-after paired set. Had they done that, the scan reading would have truly been “blinded.”

As things were actually done, however, there could have been a tendency for the scan readers to toss the scans showing a small plaque reduction from baseline and to try just a little harder to interpret the scans which showed a significant plaque reduction from baseline.

Anyone who thinks ethics alone would prevent such behavior has a lot to learn, IMHO. In science and medicine, investigator bias should always be suspected unless you can prove that it was impossible.