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Biotech / Medical : Lifecore Biomedical (LCBM)
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To: brad greene who wrote (36)1/23/2000 9:13:00 PM
From: GregSL  Read Replies (1) of 43
 
Brad- perhaps you should look into what steps are required for FDA approval of a drug. Pre-clinical trials lead to an Investigational New Drug (IND) application. The IND must pass through Phase I, II, and III clinical trials. After satisfactory completion of those trials a premarketing application (PMA) is filed. As part of the FDA consideration of a PMA, an advisory panel gives their opinion on the drug. The FDA considers the panels advice and the information in the PMA in deciding whether or not to approve a drug.

I have not dug into CHAI any further than the link you provided. However, the information provided does not show them to be as far advanced as you believe. They have one product approved - "CLINICEL©, an externally worn silicone-based device to be applied to intact skin for diminishing unsightly scars and associated discomfort." This is approved for external use and has no role in reducing adhesions. Of their anti-adhesion products, one is in early clinical trials and two are in pre-clinical trials. They have a long way to go before being considered for approval.

By contrast LCBM is much further along. Intergel has completed Phase III clinical trials for open laprotomy and has a continuing Phase III trial for laproscopy. It was disappointing to see the advisory panel rule against Intergel. However, the FDA does not have to go along with the advisory panels recommendations. Hopefully, LCBM will be able to address whatever weakness the panel saw and convince the FDA to rule in their favor.

Regards,
Greg
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