An­oth­er refuse-to-file for a small biotech — is the FDA us­ing RTFs to man­age its work­load?

As the reg­u­lar flow of NDA and BLA sub­mis­sions con­tin­ues to pick up, it’s lit­tle won­der that an al­ready Covid-be­lea­guered FDA seems to be in­creas­ing­ly turn­ing to refuse-to-file let­ters as a means to pro­vide in­struc­tive feed­back, and per­haps even to slow the pace of its work­load.

The lat­est RTF let­ter, dis­closed Thurs­day by Ae­glea Bio­Ther­a­peu­tics, a pen­ny-stock, clin­i­cal-stage biotech com­pa­ny calls for new ef­fi­ca­cy da­ta to be in­clud­ed in its BLA for pegzi­larginase for the treat­ment of the rare, pro­gres­sive and de­bil­i­tat­ing dis­ease char­ac­ter­ized by high lev­els of argi­nine, and known as Arginase 1 De­fi­cien­cy. The com­pa­ny’s stock price fell by more than 40% on Thurs­day.

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