The exact protocol for FDA being followed ?

Can you list 1 FDA denovo approval as invasive as RADIOGEL?

That will help prove the point of fda protocol.

Can you list 1 FDA denovo approval as invasive as RADIOGEL?

Post 1 example of an FDA denovo approval as invasive as RADIOGEL.


Just post one example. Anybody.

Is aloe vera for sunburns injected into or around organs in the body?

Can you list one DENOVO approval as invasive as RADIOGEL?

Can you list anything approved through the DENOVO pathway that's as invasive as RADIOGEL?

NOPE

Clinical trials in 6 months? ? Wow.

It will take years and millions of dollars.

Yes leave it in Dr. Fishers hands.

He's met with the FDA and he stated they suggested animal and human testing.

Jim has been working on this for 10 years and he's still at step 1 with a 50+ million accumulated loss.

But cant expect approval because hes never done the proper testing. Amic is probably just a hobby.

AMIC is attempting to classify radiogel as a class 2 device which the FDA stated in the denial letter of the last denovo that they dont believe its eligible for the denovo program because of the risk level of radiogel.
Would you like the denial letter posted?

FDA said in that letter
"Nor do we believe your device is of low to moderate risk and thus eligible for denovo."

Fda.gov shows class 2 examples: condoms, wheelchairs, and pregnancy kits.

Fda.gov says examples of class 3 are: injectable and sustains life.

What is radiogel closer to a pregnancy test or an injectable item?

Is submitting to the FDA without their suggested testing a good plan?

Is circadian credible if they are claiming FDA approval April 2016?

It's 1/30/16 today?

"LSDF funding will support preclinical testing of radiogel delivery, biodistribution, safety, and therapeutic efficacy as a precursor to clinical trials."

"PRECURSOR TO CLINICAL TRIALS."

ANIMAL TESTING IS A PRECURSOR.......

maybe its a typo?


https://www.lsdfa.org/profiles/fisher2


Maybe this was a typo also

Market understands at this point human testing is needed.

Any submission without it will not have the same rally leading up to the decision because the market understands what is needed to be approved.

FDA rally with only animal testing will not be a real rally this time around.

Might as well focus on ISOVINO the wine company.

"Nor do we believe your device is of low to moderate risk and thus eligible for denovo " --fda denial

Fda said in the denail denovo not the correct pathway. Can post or email denial letter

Is circadian credible if they are claiming FDA approval April 2016?

Todays date 1/28/16

No that's what the FDA said.

So as someone who has knowledge in the industry as you claim to ......is circadian credible if they are claiming FDA approval April 2016?

Its 1/28/16 today

You are saying that Radiogel's risk level is closer to pregnancy kits, wheelchairs, and condoms for class 2?

Rather than something thats "injectable and sustains life " class 3?

Fda denial letter stated:

"nor do we believe your device is of low to moderate risk and thus eligible for denovo ".

So when the fda says in the official document that they dont believe Radiogel is eligible for denovo the fda is wrong? Or is it a misprint?

You said fda April 2016 just like the bio trader article right?

FDA approval April 2016?

The market understands that human testing will be needed.

It may not be "REQUIRED" but it's needed.

Waiting for what from the fda? Theres nothing going on with the fda.

AMIC is doing animal testing and trying not to do the human testing that the fda suggested they do.

Looking very wobbly. i thought everyone said FDA approval by April 2016.

It probably is great wine, cheers.

It probably is great wine, cheers.

Only jim would name his new wine company after isotopes.

ISOVINO

https://trademarks.justia.com/853/97/isovino-85397847.html


Another good one- the creator(or family) of radiogel SCHENTER attempting to trademark an ISORAY product.

http://www.trademarkia.com/mobile/trademark_detail.aspx?sid=86318828

Diverting questions again.

I asked you. Is FDA approval possible by APRIL 2016?

Thats a question.

Its 1/27/16 today.

So approval is possible by April?

Its 1/27/16 today.

Its January 27th 2016 today. Someone is believable if they say FDA approval April 2016?

Seems pretty fast wow. As its 1/27/16 now thats only 2 months away!!!! Did the FDA get new programs? Please post links to these new super fast programs wow.

FDA approval april 2016 or did you mean 2020? 2 months from now even tho its not even submitted yet?

Thats fact on an FDA document. Fda says in plain English that they dont believe Radiogel is meant for denovo submission and that is provable from the denial letter.

"Nor do we believe your device is of low to moderate risk and thus eligible for denovo "

If you have an official document from the FDA thats states otherwise please post it. Im sure potential investors would be happy to see your proof- It will help your argument that this is going up.

"Nor do we believe your device is of low to moderate risk and thus eligible for denovo."

Thats a quote from the fda denial. They said denovo is a no go. Can post the denial letter in screenshot.

Radiogel as a whole product (y90 and gel etc) is considered a medical device by fda. AMIC will attempt another denovo even tho the fda said they dont consider radiogel moderate to low risk.

"Nor do we believe your device is of low to moderate risk and thus eligible for denovo" --fda denial

Quote from denial saying denovo sounds like a no go.

radiogel is a melting injectable radioactive device. Below are links to fda classification examples. Class 2 devices are low/moderate risk which denovo has to be.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/ucm142523.htm

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm203018.htm


fda has examples of class 1 2 and 3 and pretty simple to see radiogel is a class 3 perfect candidate. But class 3 involves human testing which takes years and millions of dollars.

Messages confirming from government agency sources that human clinical trials have been suggested by the fda, but amic will be attempting to submit a high risk product to a low risk category again without the suggested testing.

"Nor do we believe your device is of low to moderate risk and thus eligible for denovo"

That quote is straight from the fda denovo denial.
They are submitting again thru denovo class 2 even tho the fda clearly states its not the right avenue.

Class 2 examples on fda.gov are condoms, wheelchairs, pregnancy kits, etc.

Class 3 examples "injectable, sustains life ".

Links to government agencies confirm human testing was suggested.

Seems pretty simple.

Everyone came today to watch admd go up!

Post a link!

FDA WILL LAUGH AT ANOTHER DENOVO.


Newsflash- denovo didn't work.

REVERSE SPLIT WILL WIPE INVESTORS OUT

Maybe you've been trading a lot of NYSE and nasdaq stocks but in the otc reverse splits history is disastrous for investors. Thats been proven time and time again.

Heres some otc reverse split examples.
http://investorshub.advfn.com/Reverse-Splits-3017/

Companies change their names during reverse splits a lot because of the negative stigma with the RS.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/ucm142523.htm

Class 2 products aren't even in the ballpark of radiogel. Class 2 is motorized wheelchairs, condoms, pregnancy tests.

Class 3 "injectable and sustains life".

This isn't proof but common sense.

...................


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"

This says animal testing is a PRECURSOR to human testing.


...............

This email from the government agency is self explanatory.

5-10 million to manufacture radiogel to "hopefully create" a market sounds like risky. Especially with AMIC'S track record.

Before they spend 5-10 million to get into a market that BARELY exists, they should try getting a real fda approval and do the suggested clinical trials so that the 5-10 million can get amic rolling on an existing market to get their feet wet. Maybe after they get any sort of revenues coming in would be a much better time to take on the high risk of animal branchyotherapy.