Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Well, since we are moving on to a new subject, I presume you now agree that there is no issue concerning Compliance with FDA, and I presume you are happy with the wording "appears to be a drug".
ok, on to interstate commerce. As the Sucanon application to sell over the counter as a herbal medication was denied because it appears to be a drug, it follows logically that there cannot be any interstate commerce.
However, the word "banned" is typically used where a company was doing something illegal, got caught, and is now banned. This is not the case with Roth/Sucanon as the company never sold the product in the US or did any interstate commerce. I would suggest that instead of the word "banned" it would be more appropriate to say "interstate commerce is not permitted at this time".
To the contrary, Roth has complied with all FDA requirements. As explained in my previous post, contacting the Compliance group at FDA is optional, not a requirement. A phone call to the FDA will surely verify this.
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.
Sorry all.....a typo...."Alan" was supposed to be "Alas".
If you want to argue "appears to be" vs "is" then let me make this statement that we should all be able to agree with:
The FDA says Sucanon appears to be a drug.
Alan, you post the same statements over and over, but never provide supporting evidence.
You state "FDA denied--never said it was a drug".
However, in the middle of page 2 of the FDA letter it states:
"Moreover, the product to which you refer in your submission appears to be a drug under the Act and thus subject to the regulatory requirements of drugs".
I highlighted the key words in red showing that your statement is incorrect.
Again, another example, repeated many time before, of using the word DENIED without any qualifications or details. This word by itself means nothing. It was denied BECAUSE it is a drug.
As for the word "scam" the FDA never mentioned this word or implied that Sucanon does not work.
First I am accused of "breaching to a veteran" (I presume you mean preaching) per post 5601. For the record, I have the utmost respect and admiration for our men in uniform, past and present, bar none.
Now, I am accused of having inside information per post 5608. Please read carefully as I used the word "pedict". For the record, I have no inside information and never have had any inside information.
You state " The IR fraudster have already announced ALL of these and NONE has happened".
Fact:
None of the first 4 events has been announced yet.
Number 5 should follow the announcements.
I predict the following sequence of events:
1) Start of clinical trials is announced
2) Clinical trials completion is announced
3) Government of India reviews and approves Sucanon
4) Sales in India starts
5) All negativity evaporates due to jump in stock price
These will be big news.
Please take a day off to honor our nation's soldiers who died in battle defending the freedoms that we have today.
You are 100% incorrect. This article was not about TYPES but rather SPECIFIC offending products and how to spot these SPECIFIC products. The Consumer Reports article was modified and posted to make is appear that Sucanon/Roth was an offending product which it was not.
The FDA sent out 15 warning letters to these companies and Sucanon/Roth was NOT on the list.
To try to associate and connect Sucanon/Roth to this is irresponsible and continually trying to defend the modification of the Consumer Reports article is morally wrong.
You state "Putting your own word into the FDA document isn't correct".
You seem to be are accusing sweetlou of modifying the FDA documents, but this is a false accusation. Sweetlou clearly stated that his comments were in parenthesis ( ) so that readers can distinguish between the FDA letter and his comments.
It is interesting that post 4477 was a modified Consumer Reports article with no indications from the poster that it had been modified.
I must also point out that the FDA language you cut and pasted here does not support your statement "The FDA clearly DENIED this scam".
Well, if you read my post carefully you would realize that I am not agreeing with you.
A Trifecta of False Conclusions!
(in hockey this is called a hat trick)
I don't believe this is a serious post.
The word "barred" implies that the company was selling in the US and was made to stop, but this is not he case. Sucanon was never sold in the US and becasue Roth wanted to sell in the US is the reason they applied in the first place.
The application was denied because it is considered a drug. If Roh was a scam then they would ave just sold in the US withut going thru proper channels (ie the FDA), but Roth did it properly "by the book" and applied.
The FDA determination is a double-edged sword. The negative is that they cannot sell in the US as a herbal product, but the positive is they can sell in the US as a drug after FDAapproval as a drug. Roth chose not to do this at this time as it is very expensive and time consuming, so they surely would do this in the future once money flows from sales in the other countries where they are approved.....Cnanada....Mexico....soon India.
The facts are undeniable:
Approved in Canada.
Approved in Mexico.
FDA says its a drug.
If you burry your head in the sand your asset is exposed.
If the shoe fits, then wear it.
The facts have been clearly presented over and over by sweetlou, myself, and others, and always with backup info and links. The facts are clear. I believe most readers have no trouble reading and understanding the facts.
FDA says its a drug.
Approved in Canada.
Approved in Mexico.
My prediction is that in a few months the clinical trials will be completed, India will approve the results, sales will start in India, then the stock price will rise significantly to new multi-year highs, then negativity will evaporate and the real investors will party hearty.
ok, I add up the numbers as you requested.
4+5+6=15
Canada is a real country (north of the US)
Mexico is a real country (south of the US)
These facts are undeniable. These are not scam countries.
Approved in Mexico.
Approved in Canada.
FDA says its a drug.
These facts are indisputable and undeniable.
Sales in Mexico are ongoing.
Sales in Canada will be starting soon.
Sales in India will start after clinical trials are completed.
Shifting Gears Subject #1:
Still looking for a resolution to False Conclusions #4, #5 and #6.
False conclusion #6.
Lack of money does not mean scam.
Bonus Comments:
a) The company has only owned Sucanon for 5 years
b) During the 5 years there was one (1) name change
False conclusion #5.
Lack of sales does not mean scam.
This is false conclusion #4 (at least).
Unaudited does not mean scam.
Link please.........(I wait)
Read the red highlight...."appears to be a drug".
So what if its 2 years old. Once a drug, always a drug.
ok....here is the actual FDA language (from the middle of page 2) cut and pasted here without modifications, editing, deletions or changes, but I did highlight the key phrase
In summary, the ingredient "Dried root radix Trichosanthes" for which you have submitted a new dietary ingredient notification is not a dietary ingredient under the Federal Food, Drug, and Cosmetic Act. Moreover, the product to which you refer in your submission appears to be a drug under the Act and thus subject to the regulatory requirements of drugs.
Here is the link to the complete letter.
https://www.regulations.gov/#!documentDetail;D=FDA-2014-S-0023-0011
Well, the fact is the FDA says its a drug. Continually using single words such as prohibited, denied and barred is not accurate.
Everyone here deserves to read accurate and complete information and to state otherwise is a misrepresentation of the facts.
Fact:
Application to sell in the US was denied BECAUSE Sucanon is a drug.
Please remember to include the words "BECAUSE Sucanon is a drug" in your future posts. I would hope that you are interested in posting accurately so as not to mislead anyone.
Actually, it is totally logical.
Think of it this way.....if the FDA had not declared it a drug, then the application would have been approved.
More false conclusions.
Prohibited not because it is a scam, but BECAUSE IT IS A DRUG!.....and it would need more testing.
You ask "Is it sold in the USA against the law?"
The answer is NO.....it is not being sold in the US
You state "FDA prohibits sale of the scam product".......but you don't finish the story.....BECAUSE IT IS A DRUG!
Remember one very important point.
When the news came out that the application to sell as a herbal product was denied and the FDA said it was a drug, the stock price popped to .035.
This is proof that investors read the news as positive as bought stock.
Well, the good doctor, sweetlou, read the FDA letter and says that the FDA says its a drug. Sweetlou has the credentials and credibility.
I also read it, and as an engineer, I have over the course of my career read and deciphered many specifications and other documents and I agree with sweetlou.
Sweetlou has made his case over and over, point by point.
It is irrefutable - Sucanon is a drug.
Torman, you have just hit the nail squarely on the head!
This is why Roth shareholders are shareholders.
Well, that is the deal. $85 million over 5 years after clinical trials are passed. Its not talk. Its in the press release.
Stockmaster, just for the record, I believe the figure is $85 million and that is over a 5 year period.
Yes, FDA approval is not required to distribute in India, but India does have to approve and it is most likely that the 12 week trial will show results consistent with past tests and approval would be granted by India.