As is made clear in the article, the term "drug" includes:
The PR just confirms that this necessary step in preparing the product for sale is complete. The company is making a factual statement that by obtaining an NDC, it is in compliance with FDA requirements and that Emesyl can begin the manufacturing phase. Where is the attempt to deceive ? I don't see any words implying that the FDA has "approved" this product ?
Are you suggesting that investors should not be made aware of hurdles that are being crossed in the process of preparing Emesyl for public sale? Should the company avoid issuing PR's for fear that information could be misconstrued ? How would we know what was going on ?
Other moderators: The claim that "the NDC PR and related ballyhoo was put out there simply to allow ITNS' paid stock pimps to conflate and confuse allowance of an NDC code with NDA approval" has no real basis, as I have explained in my post. I request that post #22188 should be 'unstickied'.