harlem,
Well, I too would like an indication of some kind as to where the SMD trial/AMD trial stand. After the FDA cleared the way the next step prior to initiating the trial is IRB approval of protocol etc. Once that is done data can be forwarded to clinicaltrials.gov and you are on the way. That has not happened yet and the end of next week will be 3 months since SMD was approved. So my question is, has ACT received IRB approval and have chose not to start trials for some reason? Or, IRB has not issued approval? If not, why not? On January 3 when ACT announced their second IND was approved(AMD) they included the following at the end of PR..that was 37 days ago so "shortly" was either a poorly chosen word or something has changed.
"Specific inclusion and exclusion requirements and Investigator contact information will be posted shortly at clinicaltrials.gov. Patients and their caregivers should refer to this source rather than contacting ACT or its representatives."
IMO, I see the trial(SMD&AMD) time lines being pushed to later than ACT originally thought and Myoblast Phase 2 being moved up to possibly first quarter. So I wouldn't mind an update/direction either harlem..
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