Cell and gene ther­a­py con­sult­ing firm sub­mits draft AAV pu­ri­ty guid­ance to FDA

Back in Sep­tem­ber, the FDA held a two-day ad­comm on gene ther­a­py. At the time, hopes were that talks and dis­cus­sions could of­fer a clear di­rec­tion for the field’s fu­ture — and peo­ple came away dis­ap­point­ed as no sol­id rec­om­men­da­tions or con­clu­sions were of­fered. An­tho­ny Davies, the chief be­hind Dark House Con­sult­ing, a cell and gene ther­a­py spe­cial­ist firm, said at the time that the ad­comm was “a missed op­por­tu­ni­ty.”

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