'Y­ou are not the drug spon­sor': FDA de­clines pe­ti­tion to anoint Cas­sava's drug as 'break­through'

A cit­i­zen asked the FDA last Oc­to­ber to im­me­di­ate­ly give Cas­sa­va Sci­ences’ Alzheimer’s drug can­di­date simu­fil­am the cov­et­ed break­through ther­a­py tag, which short­ens the time­frame for re­view­ing in­ves­ti­ga­tion­al med­i­cines.

But the FDA said no this week, say­ing on­ly drug spon­sors can make that re­quest. The de­nial was sent to Paul Efron on Feb. 28. It is un­clear Efron’s rea­son­ing for fil­ing the pe­ti­tion and whether the cit­i­zen has a con­nec­tion to the drug can­di­date. A Cas­sa­va ex­ec­u­tive did not im­me­di­ate­ly re­ply to an End­points News email and phone call.

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