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Solid Biosciences (SLDB) Duchenne muscular dystrophy (DMD) treads water as FDA demands for more clinical protocol changes and manufacturing data

May 10, 2020 12:03pm

SLDB plans to submit the additional information before the end of Q3/2020

Just another failure to advance or staying public or keeping its place in the “game”?

The clinical hold that the FDA slapped on the program last November in the wake of a severe adverse event marked the second such interruption for the P1/2 IGNITE DMD study, in a small cohort of patients with Duchenne muscular dystrophy.

While SLDB resolved the first hold within three months, this time around regulators demanded more data.

Having laid off a third of the staff — and bid farewell to both the CMO and COO — to weather the delay, SLDB said it now plans to submit the additional information before the end of Q3/2020.

SLDB has submitted a slate of proposed changes to the clinical protocol “designed to enhance patient safety,” plus information on improvements to the manufacturing process; In response, the FDA asked for further data and analyses about the manufacturing process.

Which sending shares up +$0.06 or +2.45% to $2.51 pre-market after it fell 14.34% Thursday afternoon. It’s now trading at $2.51 — a far cry from $11, the level it was at just before it announced news of the hold, not to mention a peak of $51 back in 2018. (One Source: Amber Tong, Endpoints News)

The Bottom Line: I ask is there a silver lining in the current timing or is it a coffin to be buried?

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