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What is Substantial Equivalence
A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is at least as safe and effective as the predicate.
A device is substantially equivalent if, in comparison to a predicate it:
has the same intended use as the predicate; and
has the same technological characteristics as the predicate;
or
has the same intended use as the predicate; and
has different technological characteristics and the information submitted to FDA;
does not raise new questions of safety and effectiveness; and
demonstrates that the device is at least as safe and effective as the legally marketed device.
A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.
A device may not be marketed in the U.S. until the submitter receives a letter declaring the device substantially equivalent. If FDA determines that a device is not substantially equivalent, the applicant may:
resubmit another 510(k) with new data,
request a Class I or II designation through the de novo process
file a reclassification petition, or
submit a premarket approval application (PMA).
What is Substantial Equivalence
A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is at least as safe and effective as the predicate.
A device is substantially equivalent if, in comparison to a predicate it:
has the same intended use as the predicate; and
has the same technological characteristics as the predicate;
or
has the same intended use as the predicate; and
has different technological characteristics and the information submitted to FDA;
does not raise new questions of safety and effectiveness; and
demonstrates that the device is at least as safe and effective as the legally marketed device.
A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.
A device may not be marketed in the U.S. until the submitter receives a letter declaring the device substantially equivalent. If FDA determines that a device is not substantially equivalent, the applicant may:
resubmit another 510(k) with new data,
request a Class I or II designation through the de novo process
file a reclassification petition, or
submit a premarket approval application (PMA).
The FDA Classification of BioCurex’s Histo-RECAF(TM) kit.
April 19, 2004 - Source: BioCurex Inc.
More information
I am only reiterating from the horse's mouth. I don't claim to know the process, but what I do know is they have collected sufficient data over a 2 1/2 year period. Also, it would behoove Abbott to get on the stick and be first to market to gain as much exposure as possible. Everyone on this website is only stating opinions. I don't know for certain nor do you. What we all agree that we will finally be taken seriously. The stigma of it's too good to be true, thefore, it cannot be, will finally end.
I feel a need to correct you. First, this is a classified as class 1 which is very rapid. Secondly, what do you think happened to all the data collected during the testing phase on the analyzers? This is what will be sunbmitted. Also, add Goshen, Bhlokin, and quite possibly other phamaceutical companies and this leads me to believe we are closer to submission than you think. Reread anything in the previous press releases quoting Dr Moro and you will deduce the same thing I am telling you. It is a difference of opinion only, and it is my opinion you have yours.
Please review information from link.http://www.otclive.com/BOCX_Initiation_Report%5BTSC%5D.pdf
This only a review, but is helpful.
We are probably almost ready to submit to the FDA. I you remember what Terry said to Pocket "we have been working feverishly with both Goshen and Bhlokin." You know this is where the samples must have come from, and the data corroborated. I don't know how much data is required for submission to the FDA, but there is obviously enough for Abbott to be satisfied to release this in front of the most respected doctors in cancer research.
We have already arrived at the gate and are just waitng for the door to open my friend.
It is getting close to game day and it is time for everyone to put their differences aside and strategize on the best way for Biocurex to get its just due.
What I'm getting at is we should consider the best way to give Terry ideas on how to get the word out about what is going to happen to modern medine and worldwide health care as we know it.
Other than the major publications and news sources we should notify all diagnostic and cancer treatment centers, medical universities, institutions for cancer research, health care providers, and insurance companies to give the story legs.
This should be on headline news and presented as a major medical breakthrough. We are all excited about Recaf and now that it will be proven and useful in diagnosing cancer the word must get out in a big way. We will have proof and able to demonstrate it. In simple terms, if you want the world to know.... you must let them know.
This stock won't look back in share price unless there is someone with an agenda to hold us back, but at an average of 150,000 shares being traded 5 days a week for three more weeks there will eventually be a point when there are no more shares for sale. We have already risen 38% from the bottom and the news isn't even out there yet.
I wish I could answer that, but you yourself said scientists are not the best businessmen.
The anticipation is tough, but everyone associated with this board is well aware that in about three weeks time at the ISOBM we will get these answers.
Pocket Lint, after the meeting you won't even have any room in your pockets for lint, because they will be stuffed with money!
He wanted the money immediately so he could continue working on theurapeutics.
What 2nd placement? This is a hypothetical not a definite.
I don't think we are asking for more money at this time. We are about to receive money from Abbott.
My understanding is that we have a finished product. I remember reading that Dr Moro is focusing on his other pet projects now.
No one on this board should even try and predict what the share price will be, because until we hear from Abbott it is a meaningless debate. We can all agree that the price will be much, much higher. I'm sure Abbott will give projections and we will have answers. The question will be after we are on the AMEX what multiple will be given to our company.
I hope that they remember to put the stock symbol next to the company name on any future meaningful press releases.
300k is alot of pocket lint. Sounds like you'll be buying the champagne for everyone. I'm glad you talked with Terry. His job is to propel us into major media. I cannot express the importance of what is expected from him from a shareholder's standpoint.
He is the link to the outside world and future SAVVY investors. Not daytrading manipulators.
It is highly likely we will continue seeing large block trades pushing us higher. As we approach the ISOBM there will be some panic buying, because those "in the know" realize how important the meeting is, and it will give us credibility and reassure investors that Abbott is going to be first to market with Recaf.
As soon as this information is released at the meeting Terry (our newest pr guy) will pounce on this opportunity to get us maximum exposure in the mass media not the b******* small time penny newsletters and the share price should begin to reflect what is actually going to change modern medicine as we know it.
There has definitely been an extra bounce in my step every morning.
Go to Patentstorm.com search by inventor.....type in moro....
patent is for detection of cancer using antibodies to the alphafeto protein receptor. The most important part of the patent is the section about the summary of the invention. The patent is for detecting cancer, treating cancer, monitoring a patient, treating a patient with cancer, treating cancer cells in a patient, and to diagnose and follow up cancer diseases.
Sounds pretty broad to me. I remember Dr Moro saying that the patents have been modified as his research has lead him to more uses and greater discoveries for Recaf.
Please check it out for yourselves.
Shouldn't we be questioning Combupharma on the use of our discovery without consulting Dr Moro?
I believe the way in which the antibodies are delivered to the receptor is what is patented. Dr Moro's expertise is unparalleled and this is why he will succeed.
Constab copied our website. Go to their website and click on PLATFORM then play their animation of the delivery system. Doesn't that look familiar?
As far as others working on therapeutics, after Dr Moro was put to the task and forced to change the test from RIA to Chemoluminescence and succeeded I feel very comfortable saying that he has the most intricate knowledge and understanding of AFP. His end goal is to find a cure and he has shifted his focus entirely on this.
I think he will have gained an extreme amount of credibility after the meeting and there will be many others interested in any future endeavors he will be involved with.
What happenened to our patent protection?
In one month we could easily buy this company and Dr Moro can take the ball and run with it.
This company is going to be very interested in what is being said about Recaf at the upcoming ISOBM.
The plot thickens.
Those of us who share our thoughts and due diligence on this site can piece together what a rare oppportunity this is.
Tommyb, you nailed it. This also a Canadian company and they definitely have strong ties to Biocurex. It is difficult to see the references but it certainly says...... R Moro, "a new broad spectrum cancer marker".
I assume we are in the mix. They have established a completely new pharmaceutical company based on Recaf. Doesn't that speak volumes for our technology. There is no denying we will become a major company. This is more evidence of what we own patents for and have the leading scientists in cancer marker field to continue to making further strides in new applications for Recaf.
I am very pleased with this news. Unbelievable find! We just keep hearing more validation each day.
Great find, tommyb.
The data from the testing on the Architect system is what will be sent to the FDA. There is no reason for Abbott to delay the application. We should check the FDA filings under Abbott and see if I'm right. That would be amazing if we are that close.
I come back to Bhlokin Cancer Center, and I think that was where a majority of blood samples are from. We should have compiled plenty of data to satisfy the FDA.
Someone with the know-how please check the FDA filings and let us know what you come up with.
Thanks.
I hope that after the meeting and the release of the data that Biocurex will have the upper hand in regards to control of what is being done to promote Recaf. Abbott has been a mixed blessing. We all know the company would have floundered without their support, but we have been at their mercy.
We need to inform all the cancer research centers worldwide what has been discovered and VALIDATED.
Stop with the small cap newsletter and notify the WallStreet Journal.
I bet Carl Icahn would be all over this company just like Imclone.
After looking into PLX the main contributing factor was the people involved. They had investors which were extremely successful with previous ventures and that was good enough for investors. They were a start up company and bought a shell from Orthodontix on th AMEX which was bought out. Now the y are about to go to clinical trials, and they have been compared to Dendreon and Imclone.
At this early stage of our company, the difference with us is we won't find out later that a drug we created has harmful side effects. We are selling the technology only. It has already been proven.
Maybe some time soon we will get some information out of Blokhin Cancer Research Center concerning the use of cancer detection on patients in their hospital in Russia...we do have a signed agreement with them and this would also confirm independant data. According to Dr Moro, the whole idea was to use Recaf in a natural environment. Did anyone notice any names contributing to the abstracts or presenting at the ISOBM from Russia?
Pocket, I posted this information about PLX because I felt that there were definitely some similiarities. They raised funds thru the sale of shares and have achieved success by being on the AMEX. We should be on a better exchange very soon. These aren't my words, but the words of Dr Moro. We will have to trade at a reasonable PE, but you see what happens when there are just the prospects for a possible discovery.
The thing that caught my eye was this company traded very thinnly, under 100,000 shares a day at around .60 and ran up to 58.00. Like you mentioned as did I, THEY DO NOT EVEN HAVE ANY MARKETABLE PRODUCTS AND NO REVENUE! Can it happen to Biocurex?It is entirely up to the marketing strategy and the ability to get adequate prand the proper investors. We need to spend some time and really research how this company went from obscurity to a billion dollar market cap.
Actually, I just looked at the share price today and it is up 5.00 to 44.00.
I, like many others chimed into this website, but let Bocxman do all the speaking, and fight all the battles coming from the naysayers. He was strictly in command, because he seemed to have all the right answers. Mysteriously, and I deeply regret, he just vanished. We all know the last time he contributed to this board his health was failing and he was in the hospital.
It is fair to assume that our friend of Biocurex has passed away. That was about the same time accusations and the mud slinging really began, so since I feel so passionate about this company and Dr Moro's life's work that I felt a personal need to express myself.
Gold, at first I thought you must be a plant from a competitor or were in some way compensated to disrupt the board and shake things up to cause doubt. That is why I can speak for everyone when I say your more recent positive opinions were a sign of good things to come. Don't take this the wrong way, because my opinion of you is much different and now appreciate your contributions to the board. {Just as you thought I was Dr Wittenberg for defending Dr Moro}.
The smartest thing that Biocurex management has recently done was hire this new pr firm. This will allow everyone at the lab to do their jobs properly without having to stop what they are doing and answer the shareholder's questions. Terry has a history of getting good press and is up to the task. He just needs the green light and it will happen.
These are exciting times and we will all look back at this as just the first step toward ridding humanity of all the unnecessary suffering.
If you have ever seen a child suffer or a family member suffer from cancer you would do anything possible to find a cure. It will be a much better place when we wake up to find that Biocurex has achieved this. Let's hope that the medical community embraces us, and we collaborate with the best of the best in the field of oncology. The latest comment by Dr Sell will ring true amongst the previous naysayers, and as was recently stated there were no known universal cancer markers known to science......until the ISOBM. Ladies and gentlemen, history is about to be made.
I even mentioned to them quite some time ago that every time they say Biocurex in a press release they need to put the stock symbol next to it. They liked the idea. It is funny how a while back I was ridiculed for saying Biocurex should sell some of their shares to raise money to get onto a better exchange or for a future nest egg. In effect this is exactly what happened to raise 3 million in cash.
According to Dr Moro, getting on a better exchange is a priority on his agenda which he has, and will continue to deliver. I remember when the SEC halted the stock without merit after it surged on over 20 million shares from pennies to over 4 dollars in a single day. He could have paid a fine and we would have gotten off the pink sheets months earlier, but he felt personally attacked and he did not want his reputation unwarrantly marred, so he will make it a personal thing to be on a better stock exchange. IMO it will happen very soon. This just another piece to the puzzle and will give us much better exposure.
Bob, we will not have to wait until September for this stock to pop. The word is already getting out. The turning point was when GoldSeeker finally came to the realization that Biocurex IS for real. Notice we now have Zolax on board who was very pessimistic. Over 4 years of endless questioning and delays it is nearly time to celebrate. It is funny how this has become the only stock I feel sure of and feel more at risk with my other investments in my portfolio.
Nice.Thanx Half. He is definitely referring to Recaf but I wish he had elaborated and mentioned Biocurex. He probably cannot until the meeting.
Soon, they are going to have to ammend this article to say they have now just learned of a cancer marker which can effectively diagnose ALL cancers at any stage of disease. It is called Recaf, and was discovered by Dr Moro, the lead scientist and CEO of Biocurex.
Gold, you have an interesting point when you say that the abstracts are authored by Abbott. That is key. It is important that our next press release stress this point. I believe that any normal person may not put two and two together when reading this information and realize that this is basically being published on behalf of Abbott unless I am mistaken and this is explicitly mentioned in the article. If you just read the abstract and did not attend the meeting, the scientists involved may not disclose they are from Abbott and it could be misconstrued that they are part of Biocurex.
Corrorboration of the data independantly, that is what will get everyone excited.
Remember that Terry's job {our new trustworthy PR guy who is not a penny pumper} is to see us get exposure in something that will be major such as WallStreet Journal, BusinessWeek, Forbes, Barron's, CNN, or CNBC.
All of us went into this knowing that as an investment it was either a zero or something that will change health care as we know it.
What hooked me originally was the list of Who's Who on the scientific board of Biocurex. There is no way that the original doctors which discovered PSA, CLA, CEA would associate themselves with our company if they didn't realize that the likelihood of Recaf becoming a new cancer marker were very good.
NEW FIND!!!!!!
I urge all to go to a website:
http://www.tc-cancer.com/tumormarkers.html
It came out today and addresses the need for a general cancer marker which they say today is unavailable {not for long!}. They speak about AFP and quote Dr Sell "AFP is the single most discriminating laboratory test indicative of malignant disease now available."
Where did I see Dr Sell's name before? I could wrong but doesn't this bode well for Recaf? Isn't that what he was referring to?
We are on the radar of Kgoodrich who has his own website about seasonal trends of stock's performance. I don't know how many trade upon his recommendations, but checking his previous posts he scours the internet and has locked onto Biocurex. He chose us on technical analysis and has no idea what he has found.
Dr Moro always sounded like he could never understand the price of our stock being where it's at but realized that things would take care of themselves. Now we are finally beyond the point of potential and at the point of realization.
Check out profile on Kgoodrich. He has some very interesting links. Definitely a momentum player.
Bottom line.....I'm very excited.
Gold, now that you have satisfied all your suspicions is the upcoming meeting going to break down the rest of the barriers and cause others to finally realize what Dr Moro has discovered? Your credibility is by far the most important to all who have been contributing to this board and to the many others who voyeur in. These seem like exciting times and have taken the sting out of what is going on with the rest of my portfolio and the stock market in general. You definitely have given this stock some tough love which in hindsight was appropriate.
Your methodology and understanding of Recaf has lead me to that conclusion you were a doctor, which is only important, again, because if you as with the rest of the scientific community are convinced that Dr Moro quite frankly may have, for a lack of a better word, have discovered the Holy Grail for cancer then my over 4 years of patience will have a happy ending.
There should certainly be a "buzz" around the meeting about Abbott and Biocurex. All Biocurex needs is corroboration of the data, and we will all not only be wealthier, but also know that the chances of any one of us or any one close to us will have an opportunity to catch cancer at a treatable stage and avoid death or unnecessary suffering.
From the recent GoldSeeker post, I noticed from his inquiry to Tumor Biology we need to address GoldSeeker as Dr GoldSeeker which explains his implicit knowledge of the mechanism by which Recaf works and its potential. Recall his attitude 6 months ago. It caused a great amount of frustration for most of us longs, but the recent complete reversal by Dr GoldSeeker is exactly what we should see happen at the upcoming ISOBM.
Up in premarket. Is this a tell or what? I did not know that this stock could trade in the premarket.
I agree with everyone commenting on the fact that Gold's recent excitement has caused everyone who has followed this board for an extended period of time to feel we are breaking down all the barriers of speculation {and as we all know Gold originally put the fear in all of us}.
I noticed a stock going across the ticker on CNBC with the symbol PLX and noticed this stock's recent upward momentum so I looked at their chart and recent 10Q and went was suprised to see that in about the last year and a half this stock went from around .60 to 58.00 now trading in the upper 30's. They are working with the protein ACH {acetylcholinerase} and have NO REVENUES only a hope and a prayer. Their burning thru tens of millions of dollars.
I feel in the very near future we will have the means to get off the OTC BB and when we begin focusing on therapeutics we should see similar price movements. Things are finally beginning to get interesting.
Abbott is the primary sponsor of the ISOBM and all our waiting will come to fruition. I hope Dr Moro will eventually be the recipient of a Nobel Peace Prize once his research is absorbed by his fellow colleagues. He has such conviction that all who have been patient will be rewarded greatly.
How relevant is it that Dr Moro is a board member at the ISOBM? Is this something that is attained by paying a membership, or is his credibility now being recognized? I hope it is the latter.
I expect a press release tonite or tomorrow if management has any common sense to update its shareholders. This could turn into a positive if GE is aware of the potential. They agreed under the terms set forth by Abbott prior to dissolution of the takeover. Let's all pray that they will continue the relationship as a separate partner. IMO Biocurex obviously knew that this was a possibility, hence, the 3 million dollar placement. Smart move.
Now what?
How could GE comment on something they only potentially own? When it is official there will be strong interest and I'm sure there will likely be news and press releases. This is exactly what Mr Johnson's job is. His phone # is at the end of today's press release. He seems eager to answer any shareholder questions or concerns. I advise all shareholders to call him.
I am also pleased. Let's hope that we take the high road from this point forward. Terry Johnson (the newest pr guy) was told his job is to get out the word thru major news releases such as Wall Street Journal or CNN. I spoke with him and this will happen but it important for Biocurex to get all there ducks in a row. This a locomotive just starting to get traction.