Replies to post #182309 on Biotech Values

[bladerunner1717]

re: GERN

Nuere, the partial clinical hold was lifted in June, 2014. So I'm not sure why you think this is a big deal.

Removal of Partial Clinical Hold on Myelofibrosis IST: In June 2014, the U.S. Food and Drug Administration (FDA) removed the partial clinical hold on the investigator-sponsored clinical trial of imetelstat in myelofibrosis (Myelofibrosis IST). The partial clinical hold was placed in March 2014 due to a safety signal of hepatotoxicity that was identified in clinical trials of imetelstat. In order to resolve the partial clinical hold, the investigator, Dr. Ayalew Tefferi of Mayo Clinic, Rochester, Minnesota, was required to provide follow-up information regarding reversibility of hepatotoxicity for all patients who received imetelstat in the Myelofibrosis IST. The investigator submitted a complete response to the FDA to seek release of the partial clinical hold, and the FDA lifted the partial hold on June 11, 2014.

Bladerunner