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Aiming4

10/21/06 10:15 PM

#1614 RE: gfp927z #1613

Gfp - would the clinical hold had been lifted if the FDA had any evidence based safety concerns about Ampakines at higher dosages?

Is it possible the FDA saw something it questioned in the high dosage test data, but that the lower dose data was ok... so the hold was lifted for low dosage levels, but not higher ones?

In a nutshell, can we conclude that the hold being lifted means no anomalies at all were found in any of the data submitted to date?

Or can we only conclude that no anomalies were found in lower doses, meaning Cortex is cleared to test at those levels, but not at a higher level where an anomaly may have been found?... Aiming4.