Ann: US FDA Type C Meeting for ATL1102 in DMD, page-53

I'm not suggesting PML but still even in that regard i don't think you are ever going to get even a "inkling" from 9 patients on a very low dose over 12 months - when it took Tysabri thousands of patients and years of dosing before it popped it up.

I just think the primate data has always had a issue in it, although whatever that is has never been released publicly - Teva had a issue with it, ANP carried it out again said it was fine, FDA clinical hold and only approved the IIa on a greatly reduced dosage ?

The Type C Meeting was clarifying pre-clinical requirements and requesting the FDA consider allowing the 6 month monkey toxicity + the recent IIa human data to support a US trial.

"As part of its Type C meeting, the Company is requesting that the FDA consider allowing the data from previously conducted 6-month monkey toxicity studies, and recently obtained 6-month (24 weeks of dosing) clinical safety data in non-ambulant DMD patients, to support the longer term (12-month) dosing of ATL1102 in DMD patients in the US."

"Non-clinical requirements are to be further reviewed and agreed with the FDA to assess if and how they may impact on the timing of clinical study initiation."

Does this suggest they accept the primate tox data or they possibly want it done again ?

I just think whatever it is in the primate date is likely a real sticky issue with the FDA and provided at their request - why would they keep bringing it forward if the small trials low dose safety data was sufficient ?

We'll get clarity next month either way.