re: rick3 Hi Alpha,As I understand it, any approval process by...

re: rick3 Hi Alpha,
As I understand it, any approval process by the FDA cannot commence until antimicrobial produced in the new factory/plant is available and then trailed on US farms. People should remember that with farm food animals, they are readily available for trials (unlike with humans) and of course can be totally analysed for residuals etc. Below is the only meaningful asx announcement re a FDA fast track, that I am aware of. In many places, I have read that the drug is already FDA approved. This is a good example of how some people get ahead of themselves.

CHEMEQ LIMITED 2001-12-05 ASX-SIGNAL-G

HOMEX - Perth

+++++++++++++++++++++++++
MEDIA RELEASE

Research-based pharmaceutical company Chemeq Ltd [ASX: CMQ] today
announced that further favourable test results moved its drug -
CHEMEQ(RTM) polymeric antimicrobial - closer to approval by the US
Food and Drug Administration (FDA). The FDA has already proposed
fast-track approval of the drug.

In confirmatory data, piglets showed no adverse effects from either
ten times the recommended dose of CHEMEQ polymeric antimicrobial for
the dose-period, or five times the recommended dose for four times
the dose-period. The series of tests were conducted over a
three-month period, directed and supervised by independent
consultants.

CHEMEQ polymeric antimicrobial is an alternative to the use of human
antibiotics in animals. Excessive use of human antibiotics in animals
produces antibiotic-resistant germs, which find their way back to
humans through the animal-food chain. Antibiotic-resistance is a
major problem in hospitals around the world.

"These outstanding results were expected," said Dr Graham Melrose,
Chairman and Chief Executive Officer of Chemeq Ltd. "CHEMEQ
polymeric antimicrobial is too big to pass across the membranes of
the gastro-intestinal tract of piglets into their bloodstreams.

"We even took the tests much further than required. We tested for the
scenario of a small portion of the antimicrobial traveling across the
membrane into the bloodstream. We injected the full dose, right into
the bloodstream, and still obtained the same results - no toxicity.
These results could not have been better," said Dr Melrose.

Earlier this year, Chemeq Ltd met with the FDA and presented safety
and efficacy data relating to CHEMEQ polymeric antimicrobial for
pigs. The FDA proposed fast-tracking the application for approval of
Chemeq's drug, describing the antimicrobial as "a therapeutic
break-through". As part of the drug registration process, the company
was required to supply additional confirmatory data.

Whilst fast-tracking is quicker, it still demands the same regulatory
standards. The FDA required Chemeq to determine the consequences of
inadvertent overdose of the antimicrobial, either by too high a
concentration of the antimicrobial or by using it for too long a
period. These tests have now been completed by Chemeq and the
results have been favourable.


For more information:
Dr Graham Melrose Jane Cotter
Chemeq Ltd Monsoon Communications
(08) 9355 0099 (03) 9620 3333