Spot on Wayne, some of these companies are claiming 5% additional dystrophin as a success.
That is underwhelming to say the least - and in the case of Sarepta, the FDA thinks so too as the efficacy data doesn’t stack up.
Our PUL 2.0 results are stunning - and that is an end point that regulators agree on for commercialization.
Hope we get a parallel study in the US, for combination trial....makes so much sense.
And it also answers the question why the company suddenly accelerated FDA applications...when EMA was meant to be the sole focus.
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