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You listed the cancer market. Thats all cancer treatments.
How big is the pet branchyotherapy market for pets.
HOW COMMON IS IT FOR PETS TO HAVE CANCER. VERY COMMON JUST LIKE YOU STATED.
HOW COMMON ARE ISOTOPES USED IN PETS. NOT OFTEN.
5-10 MILLION TO MANUFACTURE RADIOGEL FOR PETS ALONE WOULD NOT WORK.
Seems like some investors around amic are a little TOO sure human testing would not be needed.
With all the proof of human testing being needed its a little odd some investors can be SO sure of no human testing.
Being TOO sure is a red flag.
FDA HAS SUGGESTED HUMAN CLINICAL TRIALS
Dr. Fiaher has NEVER said human testing wont be required. Taking words off the website does not mean he said its not needed.
He did say its needed. And on the page you are referring to that you say was updated it still says clinical trials.
The page you're referring to still says this:
" LSDF funding will support preclinical testing of radiogel delivery, biodistribution, safety, and therapeutic efficacy as a precursor to CLINICAL TRIALS. "
Posting how much annual vet bills are shows absolutely nothing. Radiogel is a specialized treatment and the average joe will not be getting radiogel treatment for his animal.
Worldwide vet bills can hit 1 trillion annual in sales and it will mean nothing for radiogel.
5-10 million to manufacture this product will be too much to get into the vet market alone.
Vet market alone is a hoax. Maybe with fda approval in 5ish years is more realistic.
Vet market is a hoax. Illusion. All for show.
Jim has stated that radiogel will take 5-10 million to manufacture. This for the vet market alone would not work.
Cant manufacturer this product to treat a few animals here and there with a 5-10 million manufacturing price tag.
Vet market is an I illusion.
Lol....big worry.
2 billion outstanding shares will become 700k! No change to the authorized!
Be worried.
1-300 and uplist does not sound like reality.
It will be closer to 1-3,000 for sure. They need room for this to fall and dilute dilute dilute.
It doesn't matter if the components are being used yet or not. FDA is considering radiogel not comparable to any of these other products already on the market and must be fully tested.
It will never go class 2....class 3 all the way pma
Radiogel has a chance. Class 3 PMA.
AMIC should be thrilled to learn that class 3 is almost exactly for products like radiogel.
RADIOGEL DOES HAVE A CHANCE. CLASS 3 PMA.
You're saying that radiogels risk level is closer to a condom or wheelchair than something injectable that sustains life ?
Seems pretty simple
CLASS 2 IS NOT POSSIBLE. SIMPLE TO SEE FROM THE FDA CLASSIFICATION EXAMPLES.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/ucm142523.htm
CLASS 2 EXAMPLES:
MOTORIZED WHEELCHAIRS, PREGNANCY TESTS, CONDOMS
CLASS 3 EXAMPLES :
"INJECTABLE", " SUSTAINS LIFE".
Dont have to be a radiologist to figure this one out.
Dr. FISHER CLEARLY STATES THE FDA SUGGESTED CLINICAL TRIALS. ITS NOT AN OPINION ITS A VERIFIABLE FACT.
Dr. Fisher states this in this link you provided.
" LSDF funding will support preclinical testing of radiogel delivery, biodistribution, safety, and therapeutic efficacy as a precursor to CLINICAL TRIALS."
the key words i take out of that quote are
PREclinical
PREcursor
CLINICAL TRIALS.
DR FISHER SAID CLINICAL TRIALS ARE NEEDED.
Dr. FISHER SAYS RADIOGEL NEEDS CLINICAL TRIALS
HUMAN TESTING IS NEEDED. DENOVO IS A SCAM.
REVERSE SPLIT WILL DEMOLISH ALL INVESTORS
Some AMIC investors time the trades exactly perfectly. What a nice luxury while others have to actually trade it like a market.
FDA class 2 products are condoms, motorized wheelchairs, pregnancy tests, etc.
Where does high dose injectable radiation fit in class 2.
" If the de novo is declined and if we obtain funding to permit us to continue operations, we will explore steps toward seeking approval for the device as a Class III medical device. Generally, the time period and cost of seeking approval as a Class III medical device is materially greater than the time period and cost of seeking approval as a Class II medical device. If the Company seeks approval as a Class III device, human clinical trials will be necessary. Generally, human trials for Class III products are larger, of longer duration and more costly than those for Class II devices. If human clinical trials are necessary, there will be additional cost and time to reach marketing clearance or approval. Unless we obtain sufficient funding we will be unable to do the foregoing activities."
This was from a PR while waiting on the denovo decision from the fda.
Jim said if the denovo is declined it should go to class 3. DENOVO WONT WORK ! HAS TO BE CLASS 3!
No chance of class 2 denovo. ..
http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/ucm142523.htm
Class 2 (all denovos class 2) examples are
PREGNANCY TESTS AND MOTORIZED WHEELCHAIRS...CONDOMS ARE CLASS 2.
Class 3
"Implanted" and "sustains life"
THE CLASSIFICATION SEEMS FAIRLY EASY ACTUALLY.
" LSDF funding will support preclinical testing of radiogel delivery, biodistribution, safety, and therapeutic efficacy as a precursor to CLINICAL TRIALS ".
-Dr. Fisher
fisher says human testing
Condoms and motorized wheelchairs are listed as class 2 with the FDA.
Is the risk level of radiogel ( melting injectable radiation ) comparable to a rubber or wheelchair?
Class 2 is not for radiogel. The fda will roll their eyes when they open this packet.
The FDA does not care about Dr. Fisher or radiogel specifically. If amic submitted it properly i might actually have a chance.
Class 3 PMA. Would have a chance.
Merry Christmas. Trips monday.
Maybe its the classification problem.
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm203018.htm
Fda has examples of class 1,2, and 3 devices and explanations of each classification group.
It appears denovo will not work. Maybe investors are scared this will be submitted wrong again as a denovo when that's not even the write classification group- it can only be class 3 pma.
Another good reason denovo won't work, is because denovo DIDN'T WORK.
It means your money would have been safer resting on smoldering coals.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/ucm142523.htm
On the fda website here is some examples of class 1, 2, and 3 medical devices.
Read all 3 examples- which one does radiogel sound like it would fit best in?
Fda examples of risk classification.
Class I – Lowest Risk
An example of a Class I device is a manual toothbrush. Class I devices are subject to general controlsClass II – Moderate Risk
Examples of Class II devices are male condoms and non-invasive blood pressure monitors. Class II devices are subject to general controls and special controls
Class III – Highest Risk
An example of Class III device is a heart valve. Class III devices are subject to general controls and premarket approval
Is the risk level of radiogel (melting injectable radiation ) similar to the risk level of a male condom or non-invasive blood pressure monitors? These examples are straight from fda.gov
Sounds like classification is a problem. Also amic stated this while waiting for their "expected approval" while the denovo was in process:
" If the de novo is declined and if we obtain funding to permit us to continue operations, we will explore steps toward seeking approval for the device as a Class III medical device. Generally, the time period and cost of seeking approval as a Class III medical device is materially greater than the time period and cost of seeking approval as a Class II medical device. If the Company seeks approval as a Class III device, human clinical trials will be necessary. Generally, human trials for Class III products are larger, of longer duration and more costly than those for Class II devices. If human clinical trials are necessary, there will be additional cost and time to reach marketing clearance or approval. Unless we obtain sufficient funding we will be unable to do the foregoing activities. "
https://www.lsdfa.org/profiles/fisher2
This quote straight from the page.
" LSDF funding will support preclinical testing of radiogel delivery, biodistribution, safety, and therapeutic efficacy as a precursor to CLINICAL TRIALS."
Lets say it is out of date. ...is that ok that jim failed to mention major company details to investors?
Oh its still there. Read again .
https://www.lsdfa.org/profiles/fisher2
"LSDF funding will support preclinical testing of radiogel delivery, biodistribution, safety, and therapeutic efficacy as a precursor to CLINICAL TRIALS . "
"PRECURSOR" thats black and white.
And also why would they call them "PRE CLINICAL " animal studies. If they just wanted animal studies they would just call them animal studies.
Luckily we have dictionaries
PRE (applied freely as a prefix,with the meanings “prior to,” “in advance of,” “early,”“beforehand,” “before,” “in front of,” )
Clinical studies
( Trials to evaluate the effectiveness and safety of medications or medical devices by monitoring their effects on large groups of people.)
AMIC IS DOING "PRE CLINICAL" ANIMAL STUDIES.
Seems pretty rock solid to me straight from a government agency
Just a reminder i didn't find that link.
Another long term long board member did..
It's not "my" link.
If you dont want to hear from certain members ihub has an option to set that member to ignore. Then you dont have to be bothered by their messages.
Fishers fda update was from august 2015 POST DENIAL. I will post email to the board again. Or can PM me ur email if want it forwarded direct.
Bottom line is FDA suggested human clinical trials. If amic submits without the FDA's suggested testing its another hailmary.
Nope ....just twisting words now.
Dr fisher stated to the state agency that the fda wants human clinical trials for radiogel. ...that fda update was confirmed to have been made after the denovo denial.
Or can say "suggested " or "recommended "
This is what there is proof of. Human clinical trials is definitely in the paperwork. It's undeniable.