I spoke to someone who cleared it up with the company what the ‘non clinical’ means..
Firstly..
@Akki there is no issue with the primate data. The only issue with the primate data and the P2a trial is that is was for 6 months. EMA regulations need 6 months of tox data for a rare disease.. so we are all good with the EMA. FDA requires tox data for 9 months for rare diseases (12 months for non rare diseases)... so a 3 month gap. Will the FDA give ATL1102 the go ahead or make them do a 9 month tox study??
My guess is the FDA will give them the go ahead because by the time the US trial hits 6 months and 1 day, the EU trial may be past the 9 month mark!! Does everyone Comprehend?? Ie, the EU trial data will be a proxy for the FDA tox data. My opinion only.
Also Akki.. you fool... Tysabri gets dosed at 300mg per month.. we are at 25mg and may go up to 100mg... no Antisense drug (ZERO) has had a tox issue under 200mg and over 100 of these drugs have gone through clinical trials. Please dont mention it again. Your credibility is low and going much lower with your un researched ramblings.
Mark Diamond is a very credible CEO. And quite conservative so read his quote at the bottom of the announcement and I would recommend everyone to do so again.
Good luck everyone.. not long now.
