PharmaRoth Labs, Inc. (ROTH)

[old biohf guy]

So it seems we can all agree that the FDA said "appears to be a drug". ok, not as strong as "is a drug". From now on I will use the word "appears".

Now on to Compliance. In the first paragraph at the top of page 2, it says:

"A product intended for use as a drug within the meaning of21 U.S.C. 321(g)(l)(B) is subject to regulation under the drug provisions of the Act. You should contact. FDA's Center for Drug Evaluation and Research (CDER), Office of Compliance, 10903 New Hampshire Avenue, W05 1-51 85, Silver Spring, MD 20993-0002."

I have highlighted in red the key words. The issue: Is this mandatory or optional? The word used is "should" which is not as strong as the word "must". Although the letter does not explicitly state that it is optional to contact Compliance, one might interpret this to mean if the company wants to pursue getting Sucanon approved as a drug. The other choice is to interpret contacting Compliance as an absolute requirement regardless even if the company does not wish to proceed with approval as a drug.

So, what is the correct interpretation? I believe it was meant to apply IF the company wanted to pursue approval as a drug, otherwise the letter would have used the word "must", but they did not. Also, if it was an absolute requirement then surely the FDA would have followed up with a reminder letter, but they did not.

Now, if someone really wants to confirm the FDA intention concerning contacting Compliance, all they need to do is to call the FDA. Aparently Roth does not feel the need to do this and neither do I, but if someone really thinks it is an absolute requirement, then call the FDA and post the results here please.