Hi everyone, Below is a copy of the companies announcement re fda approval lodgement.I note that the maximum time to approval is 14th june 2004. In view of the fda previously expediting registration of qftb, one would expect and hope qftb gold will also be treated the same way. In relation to Japan (we were told at the Oct 03 agm, "Approval by May 2004 is now our earliest estimate") we must bear in mind that Cellestis made the following remarks in their May 03 newsletter "with the good results and consequent goodwill we have for quantiferon gold in Japan, we hope to see faster approval". I do believe by now their must be a lot of goodwill in both Japan and USA owing to the solving of bcg vaccination testing problems, which has seen the outing of the 100 yr old skin test for giving unreliable false positives etc. Roll on registration, whichever country get's in first. Merry xmas to all on hot copper.
Cellestis Limited 1046A Dandenong Rd Carnegie Victoria Australia 3163 Ph: 61 3 9571 3500 Fax: 61 3 9571 3544 [email protected] www.cellestis.com ACN 094 962 133 QuantiFERON®-TB Gold supplement lodged for FDA approval
16th Dec 2003
The United States Food and Drug Administration has confirmed receipt of the Cellestis application requesting approval of QuantiFERON-TB Gold, Cellestis’ second generation TB diagnostic that is unaffected by BCG vaccination and other common causes of false-positive responses in the Mantoux test.
The 900 page document has been lodged as a 180 Day Supplement, indicating the maximum expected time it may be under review. Considering the benefits of QuantiFERON-TB Gold and the importance of a new test to public health in the USA, Cellestis is hopeful of an earlier approval. Nevertheless, as with all regulatory reviews, neither an early nor a positive response can be guaranteed.
The submission document contains evidence of performance of QuantiFERON-TB Gold in five clinical trials. Many other clinical trials are ongoing, in Japan, Europe, Australia, the USA, India, and South Africa. Studies to date all show far superior accuracy and reproducibility of QuantiFERON -TB Gold over Mantoux skin testing.
