Daviddal, Yes, that was an anticipatory/preemptive move which turned out to be wise. BTW, do you remember if the original 3 month tox study in two species was in dogs and rats? I seem to remember that, but no longer have my original transcribed notes to verify it (only the audio tapes of the various conf calls/presentations). Thanks.
It figures that the FDA would be pricks about lifting the hold completely. On the other hand, wanting to see a second set of 3 month tox data is understandable, particularly if the original data was in dogs, and the histo "finding" was in primates.