Bioject (OTC:BJCT) said it’s unsure of its ability to stay afloat after the FDA instituted new rules last year governing jet injection of vaccines, which accounts for about 70% of Bioject’s business, according to a regulatory filing.
In a filing detailing its inability to meet the deadline for its annual report, the Tigard, Ore.-based company said that although the new regulations were released in October 2011, a final FDA guidance isn’t expected until the 1st quarter of 2013.
"The new standard for use of jet injectors has imposed a significant additional financial burden on Bioject connected to testing of its devices with specific vaccine products," according to the filing. "Bioject is uncertain as to its ability to continue as a going concern."
The new FDA regulations also forced the company to renegotiate some of its facility and manufacturing deals. To top it all off, there were "significant staff reductions" during the 4th quarter, according to the filing.
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- Edwards Lifesciences (NYSE:EW): Brean Murray, Carret & Co. lowers EPS estimates, Sapien sales forecast, maintains "hold" rating.
- Intuitive Surgical (NSDQ:ISRG): Lazard Capital downgrades from "buy" to "neutral."
- Johnson & Johnson (NYSE:JNJ): TheStreet Ratings upgrades from "hold" to "buy."
- St. Jude Medical (NYSE:STJ): Lazard Capital downgrades from "buy" to "neutral."
- Teleflex (NYSE:TFX): Morgan Stanley "not as confident" in strategy as management, maintains "equal-weight" rating.
- Zoll Medical (NSDQ:ZOLL): Lazard Capital downgrades from "buy" to "neutral."