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Biotech / Medical : Lifecore Biomedical (LCBM)
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To: Mike who wrote (34)1/22/2000 7:17:00 PM
From: brad greene  Read Replies (1) of 43
 
Mike,

I may be all goofed up on this...but I believe the FDA approved the CHAI product for human trails and cleared every chemical and compound within it as being safe. In other words, there was nothing novel about the product from a chemical reaction standpoint.....no special chemical that could have an unwanted or unusual reaction.

I guess I would look at it like trail mix.....raisins and nuts and bran are all safe...so mixing them together should be safe also.

I think this was part of the LCBM problem....they were using a novel chemical or chemical compounds........and also the fact that the panel felt that it may not have worked very well.

I'm really not sure.....I guess the FDA can deem a Q-Tip a bio-hazard.....given the right data.

But I think for the early Repel/Resolve trials, at least...the FDA has by action, or statement, said that there is nothing in the composition if Repel that could be unsafe.

Eficacy is another deal...for sure.

bg
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