After delay, Abeona aims for fall FDA submission for rare skin condition cell therapy

In June, Abeona pushed back the time­line for its ap­pli­ca­tion to the FDA for ap­proval of a rare ge­net­ic skin cell ther­a­py. At the time, Abeona said the FDA had asked for more da­ta and pushed back its meet­ing with the biotech com­pa­ny.

Now, Abeona says it can move ahead with its ap­pli­ca­tion fol­low­ing a re­cent meet­ing with the reg­u­la­to­ry agency. The Cleve­land biotech is hop­ing to sub­mit an ap­pli­ca­tion to the FDA in the com­ing weeks, CEO Vish Se­shadri said in a news re­lease.

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