In advance of the postponed advisory panel meeting, the FDA issued a critical review of pixantrone, highlighting numerous concerns about pixantrone’s safety and efficacy.

Shares of Cell Therapeutics were down 10% to 60 cents Monday after auditors attached a “going concern” letter to the company’s 10-K annual report filed with the Securities and Exchange Commission Friday.  For the investor, if the drug works and gets approval, auditors concern doesn’t matter.  But what if the drug fails to get an approval?

Other drug of Opaxio as a treatment for lung cancer is irrelevant as better alternatives are already in the market.  So  Pixantrone approval is very critical to the company. 

Cell Therapeutics’ total share count reached more than 615 million at the end of January, compared to 296 million shares at the end of January 2009, according to SEC filings.  Whereas, in 2009, the top five Cell Therapeutics executives earned $32 million in total compensation, most of which came in the form of company stock awards.  A classic case of Executives feasting on investors money.

HOFFMAN ESTATES:  Life Spine announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing approval to the SENTINEL Occipito-Cervico-Thoracic (OCT) System.

The SENTINEL OCT System provides rigid stabilization and promotes fusion from the occiput to thoracic spine, and features streamlined implants and instruments to address complicated procedures. Polyaxial screws are available in multiple diameters and lengths, and offer a generous cone angulation, which simplifies alignment with the rod and minimizes rod contouring.

The addition of the SENTINEL OCT System to the current broad product offering is a watershed event providing the ability to offer surgeons a full range of solutions to address spinal pathologies from the occiput to the sacrum. The SENTINEL OCT System makes its mark as the twentieth 510(k) approval to date for Life Spine.

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Hoffman Estates, Illinois. For more information, please visit http://www.lifespine.com.