Replies to post #29503 on Ayala Pharmaceuticals Inc (ADXS)

[Easymoneyman00]

Are you sure that protocol would have been in place and the hold was only 2 months?

[Julius_Kelp]

FBG following that logic, where was J&J's trial design input for ADRO?
ADRO's hold occurred approx 1 year after ADXS. Where there no lessons learned by ADRO and J&J from our hold?

The company is revising study protocols in accordance with feedback from the agency, including the modification of antibiotic administration following treatment, extended patient surveillance, and, as a pre-emptive measure, exclusion of patients who are on or will receive certain immune-suppressive treatments or who have certain prosthetic devices.


http://investors.aduro.com/phoenix.zhtml?c=242043&p=irol-newsArticle&ID=2215034

[ignatiusrielly35]

David Mauro had a lack of experience running trials? And how exactly did DOC's greed cause the FDA hold?

[mastiffsforlife]

Doesn't matter who was running the trial. They would not have know to keep patients with implants out of the trial design. That's one of the reasons so many phases are run. So you can see what works and what doesn't. The only difference if BP was running the trial. The HOLD never would have lasted that long.