Ann: US FDA Type C Meeting for ATL1102 in DMD, page-61

Thank you @George1972 very informative at least someone is willing to discuss the issue

One question George ref your does everyone comprehend

How could the EU trial data be a proxy , The trial is placebo based so no data will be forthcoming for at least 16 months from the EU trial

This is an issue i would imagine that will have to be worked through before moving into any trials under the FDA guidance

I suppose an alternative to this George if it does become a major issue would be to push forwards through the FDA with a 12 month trial at the partial hold dosing of 25mg

and once the FDA trial is over on hopefully outstanding results

Then back up an early to market proposal with the FDA asking them to Accept the hopefully by then successful Ph2 trial from the EU along with OUTSTANDING results from the 100mg dosing arm

Thank you George once more for acknowledging and keeping things real and bringing common sense back to the forum

Like i said i have no reservations that this will move forwards, we will find out soon enough what these conditions are

SEE HOW WE GO