Replies to post #38968 on Ayala Pharmaceuticals Inc (ADXS)

[mm2k]

Why do you assume the submission process is completely opaque? Do you believe they wait until the last second and then throw it over the wall and hope for the best?

[gajj]

then why pray tell did they ask for what can only be viewed as very supportive data?

[Gantor50]

Catt, with all due respect you are wrong on this. If you look up the guidelines provided for the process you will see instructions encouraging companies specifically to engage in "scientific advice and protocol assistance" BEFORE submitting their official application.

They specifically state this will help speed up approval of the official submission and prevent major objections after official submission.

[ignatiusrielly35]

"They wouldn’t ask the GOG for something to aid in there decision on something they haven’t even received an application for, that’s ridiculous."

The EMA is different. They assign a "raconteur" to guide the company through the process.