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Biotech / Medical : CYBR CyberCare the new look of healthcare
CYBR 502.71+0.1%3:28 PM EST
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To: Kevin Podsiadlik who wrote (2100)6/1/2000 5:58:00 PM
From: sommovigo  Read Replies (2) of 3392
 
Kevin - CYBR had been operating on the assumption that the 200 didn't require FDA approval. However, if they had such notification before hand, the fact is that they would not have been able to 'hold' the information if such a judgement was rendered for more than 48 hours before the FDA would post that info on their site.

Now - as for taking orders for the 200 - the answer is, no - it is not a crime. However, if it DOES happen to be at odds with the FDA's regulations regarding the matter (as has been hinted at in the CA's and certainly by Herb), the FDA has clearly stated that the 'punishment' for such behavior is a letter kindly asking the company to stop it. No fines, no tussles, no nothing.

However, what remains to be seen by CYBR or by anyone for that matter - is a letter from the FDA stating anything of that sort. And, as I had mentioned to you in an earlier post, IF there were issued any sort of reprimandory letter (which would be issued if the FDA decided that CYBR was not conforming to the regulations in question), that letter would appear published by the FDA on their web site.

Although this issue is now weeks old - there is still no such reprimand to be noticed. These are public documents.

So, again - this theory of your regarding CYBR holding 'news' of the EHC 200 and the FDA - unfounded. It couldn't be that way simply because the news would have made it out through other channels even IF CYBR were to hold that info.
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