FDA to Chi­as­ma on their Phase III re­jec­tion: Come up with a bet­ter plan next time

The FDA re­al­ly, re­al­ly, re­al­ly doesn’t like Chi­as­ma’s Phase III study for its lead drug, oc­treotide. And the biotech isn’t mak­ing much head­way in find­ing a way around the reg­u­la­to­ry road­block with­out sat­is­fy­ing the agency’s de­mand for a new, far bet­ter de­signed Phase III tri­al.

Reg­u­la­tors at the agency bat­ted down the acromegaly drug, dubbed My­Capssa, last April af­ter con­clud­ing that the biotech sim­ply didn’t prove that the pill works with the sin­gle-arm Phase III on of­fer. The oral drug is in­tend­ed to re­place the in­ject­ed ther­a­pies cur­rent­ly used to treat the rare hor­mone ail­ment, in which the pi­tu­itary gland gen­er­ates too much hor­mone. And reg­u­la­tors don’t ap­pear to be too re­cep­tive to any al­ter­na­tive plans that Chi­as­ma has in mind. From the biotech’s 10Q:

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