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Re: Indaflex Phase 3

Posted by: mavenwood on October 09, 2007 11:20PM

In response to: Re: Indaflex Phase 3 by Tutty

Thanks-
I guess it's not appropriate for me to comment but I certainly don't have information that shouldn't be available to all shareholders....... well, a slight problem in that they just don't say much, particularly in regard to Indaflex phase 2 & 3. Again, paranoia regarding the competiton in relation to anything regarding Indaflex, not intended to inflame shareholders. Let's just hope the FDA meeting goes well, whenever it is. There's plenty of reason to think they'll be able to advance to phase 3. I've talked to some very knowledgable people about the clinical trial process. The fact that the endpoints were not met in phase 2 is by no means an indication that Indaflex won't advance to phase 3. The discussion is more likely to be what endpoints will be defined for this last step before approval. Remember, ALRX's consultant Dr. Simon, former head of FDA medical testing, is known to be an extremely tough guy and may have defined the test's endpoints to be extremely difficult to meet. Thus, failure to meet endpoints does not mean failure of the product.
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