Replies to post #178865 on Biotech Values

[dcsteve]

Thanks, I'm linking your opinion to the itns board if you don't mind. The creator of emesyl os the same creator of zicam. So hopefully emesyl success can be piggybacked. Yes I know zicam was once recalled but a new version is still on the market worldwide today.

[britguy2]

In my view, the only possible reason they could have for obtaining an NDC was to deceive naive investors by enabling their PR.

Total garbage! Any homeopathic product that is sold in the U.S must have an NDC number. It isn't optional:

http://www.fda.gov/downloads/AboutFDA/WorkingatFDA/FellowshipInternshipGraduateFacultyPrograms/PharmacyStudentExperientialProgramCDER/UCM255181.pdf

As is made clear in the article, the term "drug" includes:

(A) articles recognized in the official United States Pharmacopeia, official Homeopathic Pharmacopeia of the United States, or official National Formulary, or any supplement to any of them

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 the company should not have announced that it had obtained an NDC for Emesyl for fear that investors might misconstrue the information and think that the product had FDA approval ? If not, how do you think the company should have communicated the fact that it had obtained an NDC ? Is it unimportant that investors should be made aware of hurdles that are being crossed in the process of preparing Emesyl for public sale?