Imre Corp. said that FDA has granted the company "restrictedapproval" of its Prosorba column treatment for immunethrombocytopenic purpura (ITP) patients.
The treatment will be available to patients who are "criticallyin need." The company is still awaiting formal FDA approval ofits new manufacturing facility.
According to company spokeswoman Lois Yoshida, Imre(NASDAQ:IMRE) of Seattle asked FDA to conduct amanufacturing inspection of its new facility in May, but FDAdid not review the plant until December. Yoshida said FDA hasraised some issues that need to be resolved -- all of them"paperwork" issues. She said the company is cooperating withFDA to address the problems quickly.
"At this point, we are not even going to try to guess when thefinal approval may come," said Yoshida. In the meantime,patients who need it will now have access to the treatment.
Imre's column was approved by the FDA for treatment of ITP,but the approval was based on product manufactured at thecompany's older facilities. Now that a new facility has beenbuilt, another round of inspections and approvals is required.
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