The FDA can be real obstructionist. Have a look at what they did to another Australian Company, Pharmasix, late last year:
First the FDA Advisory Committe recommenda approval on 26/11/09: http://www.hotcopper.com.au/asx_announcements.asp?id=115850
Then the FDA disapprove on 29/12/09: http://www.hotcopper.com.au/asx_announcements.asp?id=135361
My personal interpretation of the FDA request from CXS is that they come up with a validated test that identifies the test patients that have (or had) the T31521 mutation. Then they have to correlate this with the clinical test results CXS already establlished. I don't believe any further testing or retesting is required. Sounds simple but CXS will have to get this 101% right to satisfy the FDA.
It will probably take a few months. Investors (or speculators) have become very impatient and don't fully understand the FDA's request. A few reassuring bulletins from CXA management would stabilise the share price, but it's clear to me that communication is not their forte.
- Forums
- ASX - By Stock
- t315i mutation testing
The FDA can be real obstructionist. Have a look at what they did...
-
- There are more pages in this discussion • 9 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
Add CXS (ASX) to my watchlist
Currently unlisted public company.
The Watchlist
SER
STRATEGIC ENERGY RESOURCES LIMITED
David DeTata, Managing Director
David DeTata
Managing Director
SPONSORED BY The Market Online