SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Gold/Mining/Energy : Vasogen-- VAS on TSE

 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
To: ddl who wrote (307)8/2/2005 2:20:27 PM
From: Pluvia  Read Replies (1) of 377
 
it's not a drug and never was. It is a device which introduces into a sample of your blood three basic elements, heat, O, UV.

actually the fda makes the decision of drug/device, not the company. the company just makes application and *attempts* to sneak thru approval as a device. the rubber meets the road at approval time.

treated blood that changes chemistry and thereby has a therapeutic effect can and generally is considered a drug.

as i have said previously, this gets more complicated for vsgn because they can't define how much of the unidentified substance that causes the effect is in the treated blood.

therefore, they also cannot define if there's more *undefined magic stuff* in one person's blood after treatment, than another person's blood. individual blood chemistry is likely affected differently...

darn, that's a problem i'd say....

will that halt or hold up fda approval? good question, i say yes.
Report TOU ViolationShare This Post
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext