PharmaRoth Labs, Inc. (ROTH)

[sweetlou]

Regarding the ongoing false statements about "phony press releases",

I addressed previous similar statements in detail regarding FDA action and so called "phony" press release issue and none of the false statements posted have been corrected. Here was part of my response for review:

A press release was distributed when the FDA responded that Sucanon:
1. Was considered a drug per the food and drug act.
2. Therefore cannot be sold in the US s a supplement as requested in the application.
3. Sucanon is a drug that already underwent "substantial clinical investigations" that were publicly disclosed.
4. Sucanon would need to go through the investigational new drug application process to be sold in the US, as FDA considers it a drug per the food and drug act.

Logically, it is inconceivable to argue that FDA response to a written request on the company's only product is not newsworthy even on its face, as this is clearly material information. It is also inconsistent to say the FDA response is "not newsworthy" but the company should release every word of a written contract with Canagen (distributor of Sucanon in India) even though per OTC market written guidelines a press release is sufficient (guidelines were posted by Hopscotch 2 some time ago). Logically, one can't have the argument both ways.

You go on to state "IT WAS DENIED and just part of a history of phony releases. Here are some of the lies"

Calling the press release "phony" is a false characterization as the announcement summarized the FDA statements listed above and can be readily verified with the link in my previous posts. The press release clearly states the denial as a supplement. As was previously stated, the denial as a supplement cuts both ways. On the negative side, Sucanon cannot be sold in the US as a supplement due to the FDA statement that Sucanon is considered a drug under the food and drug act. Also, the new drug approval process is very expensive. On the positive side of the FDA response, FDA states that Sucanon is a drug and has been subject to "substantial clinical investigations" and cites the publicly available studies as a basis.

I covered all of this regarding FDA, so called phony press releases in response to the previous similar post below:

"In addition to the FDA DENIAL and the disastrous financials including that this fraudulent scheme has 265 bucks in the bank, this scam uses phony press releases to try and gin up stock sales and fleece hapless Marks.. Here are just some of the LIES for this fraudulent scheme. All by Mike Irving and his band of fraudsters
ALL FACTS....... AND LIES"

The above statements are all conjecture, and ill conceived at that since the underlying assumptions on which it is based have been proven false. But let's briefly cover the 4 press releases cited:

1. The most relevant regarding sales in Mexico states that sales under distributor Merck SA de CV had expanded. While true, sales were still inhibited by lack of follow through from the turnover of 5 managers in 4 years at Merck and the diversion of funds by Schlosser and Squires from fulfillment of orders that harmed the company severely. The company almost didn't make it through the that escapade and went dark for about 2 years and now works with distributor MDR in Mexico and has Sucanon on shelves and online at Similares Farmacias throughout Mexico. So while there have been many ups and downs in the history of ROTH/FROI and BIOHF before that, sales have significantly increased since the time of that announcement.

2. Regarding the 2011 press releases about distribution in the Middle East, the same Schlosser/Squires debacle that brought operations to a near halt everywhere including Mexico also affected this area, with Iran specifically (the subject of the other press release) facing additional hurdles due to Iran sanctions by the UN.
Specifically the agreement with Bahestan Darou (http://www.behestandarou.com/) Iran was nullified by President Obama when he slapped trading embargo on Iran. Any who follow the company link will see they are real and work with Pfizer, Bausch and Lomb, Merck, etc.

3. The China press release was generated as the referenced company Tianjin contacted the company unsolicited about distributing Sucanon in China. They were going to pursue all the regulatory approvals required and the PR issued to disclose material information. As background, diab2 was studied in China and approved for sale there in 1997 when Rieveley ran BIOHF. I think the distributor was Volque pharmaceuticals at that time but the focus turned to Latin America with subsequent study and approval in Mexico and Peru. By the way, the name of the Mexico subsidiary at the time BIOHF first operated there was Pharmaroth, just to additionally clear up the name issue that is frequently referenced "no one named ROTH." Anyhow, the Chinese company Tianjin did not follow through as they were bought out by another Chinese company that focuses on generic drugs in India, so there is currently no activity in China nor does that company have any rights under the agreement. That does not in any of these cases equate to a phony press release at the time.

4. Just to head off the next obvious argument before it is raised, by contrast, Canagen is actively working through the Indian government approval process and is invested in the effort. Stockholders are awaiting word on the progress of approval in India and the results from the completed clinical trial in Mexico City.