If they have made this filing then it takes them into an environment of greater professional scrutiny. If they haven't then there will be a long period of silence on their website as has followed almost all of their previous announcements. Perhaps someone should ask FDA about whether this filing happened....FOI!
Monday, January 16, 2012
Filing to FDA
The Jan 11 2012 version of the press release in which Nuclea claim to have submitted a "Pre-Market IDE regulatory filing" to the FDA for their FAS/USP2a diagnostic combo is the predicted step up to yet another level. Their initial press release, (subsequently altered) stated that they had applied for a Pre Market Approval but this was rapidly altered, although it highlights their lack of knowledge of the FDA regulatory process.
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2 comments:
I've been following this whole story with great interest.
I really have no idea how the FDA filings work but isn't this approval for clinical trials? If so, who will conduct them? What medical center? I'm assuming they would have to be published?
Also, won't financial statements have to be filed too? I do the the FDA wants the relationships known between the company and associated researchers. Will all this be public?
I'm no expert on this either, but I'm talking to some people who are.
When you come up with a product that will be used to test patients for a disease, then the FDA needs to be involved to make sure everything you claim about a test is legitimate. That would be determined by submitting evidence to them and undertaking careful, controlled trials.
Search on FDA 510K and you will be in the right area. This IDE thing they are using is smokescreen to try to get the out of the hole their original PR put them in.
First one said Premarket Approval - but that'd be easy to search in the database for that type of application. IDE means there are some trade secrets involved that can't be shared in this way.
Now call me a cynic...but we're not going to be seeing any good news out of the FDA on this, the most likely reason being nothing has been filed. It's buying time and just one of the last swerves they will make before the edge of that cliff arrives.
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