Osiris Therapeutics (OSIR -2.2%) is weaker in early trading.
This is the second time this month that the regulator has raised HCT/P questions — MiMedx (MDXG +1.5%) suffered a nasty sell-off last week after the FDA said Amnion / Chorion Injectable products weren't regulated solely under section 361. (letter) The company claimed to have considered the issue closed after the Center for Biologics Evaluation and Research classified a 2012 plant inspection as "NAI".
OSIR's Grafix and Ovation are HCT/P products and some question whether the company will face regulatory scrutiny going forward.
For those interested, here's what the FDA has to say about HCT/Ps: Guidance