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http://access.wa.gov/agency
This link shows lsdf listed as a "GOVERNMENT AGENCY"
right at top of page it says
Government agencies -state agencies
Ceo and cfo didn't want shares. They had to take them because company has no money to pay salaries.
Jim is way too smart to want shares here. But if it's either take shares or take nothing he'll take shares.
RADIOGEL IS NOT A DENOVO TYPE OF PRODUCT. RADIOGEL IS CLASS 3 HIGH RISK. RADIOGEL CANNOT PASS DENOVO.
HUMAN TESTING IS 100% IN THE FDA PAPERWORK. I have an email from a government agency confirming dr fisher states the human clinical trials after the last fda denial. i can forward to anyone who wants proof.
AMIC CAN HIDE BEHIND WORDING THINGS LIKE A LAWYER BUT THATS ALL AMIC HAS AT THIS POINT IS MISLEADING PEOPLE WITH WORDING NOW THAT THE CATS OUT OF THE BAG.
AMIC CAN KEEP HIDING BEHIND "SUGGESTED", OR "REQUESTED", OR WHATEVER.....BUT BOTTOM LINE IN FDA WANTS HUMAN TESTING DONE.
even with animal or human testing the high risk level of the product might be too risky compared to the benifits
"WE DO NOT BELIEVE THAT THE BENEFITS OF YOUR DEVICE OUTWEIGH THE RISKS " -FDA
Any fda submission will be denied without the fda's suggested testing.
If the fda were to approve radiogel it would be in 2020-2022.
Thats after another failed denovo and human testing then a new class 3 submission.
Exactly
The fda definitely didn't say human testing isnt NEEDED. THEY WILL DEFINITELY BE NEEDED.
ANY FDA SUBMISSION WILL BE DENIED IF AMIC DOESNT DO THE SUGGESTED TESTING.
HUMAN CLINICAL TRIALS IS 100% IN THE PAPERWORK AS PROVEN WITH THE LINKS PROVIDED.
I cant create an email from the government.
I can forward it if you want proof.
The fda suggested human clinical trials we have solid proof i have an email from government confirming it.
Submitting to the fda without the suggested studies is wild.
AMIC intends to submit a denovo without the fda's suggested testing. (Which we NEVER heard about)
The creator of the product stated that the fda wants human clinical trials on a government page.
AMIC intends to submit without the SUGGESTED testing.
Are you saying Dr. Fishers radiogel FDA update on a government site is not credible?
https://www.lsdfa.org/profiles/fisher2
Its obvious human testing was in the fda paperwork. Jim failed to mention that part whatsoever.
Submitting devices to the fda without their suggested testing is wild.
Are you saying dr fisher is not credible?
are you saying the state of Washington is not credible?
https://www.lsdfa.org/profiles/fisher2
The letters spell the same in this link also
2020-2022 radiogel has a possibility of passing.
Thats after another failed denovo with only a small percentage of the testing the FDA stated they wanted.
So it has a chance of passing after another failed denovo with only animal testing then a class 3 pma with official human clinical trials.
This will be well into 2020+ ....been a real long time already.
https://www.lsdfa.org/profiles/fisher2
Dr. Fisher and a state agency have it listed and confirmed this update was made after the denial that the fda wants human clinical trials.
Is Dr. Fisher not credible anymore?
Is the state of Washington not credible anymore?
It appears human trials is in the fda paperwork as confirmed by credible government links and emails.
The funny thing is that if the info was swapped ( twitter says human testing IS NEEDED and a government link said its NOT NEEDED ). Then all the "investors " would be laughing at news from twitter over government links.
And the update saying that the fda wants human testing from august 2015 was written by Dr Fisher. Any other time dr fishers name is involved the "investors" take his word with the power of god but this time his words they didn't want the public to hear.
-Dr. Fisher is a credible doctor, EXCEPT THIS TIME
-Tweets are not a credible source, EXCEPT THIS TIME
-Government links are a credible source, EXCEPT THIS TIME.
So resilient that it went from 75 cents to 5 shares for a penny in a couple years.
That is resilient. Good call.
Thats tremendous good find. Man, this should be taking off i guess.
Nevermind the 1-3,000 reverse split or that the company wants to submit to thd fda without proper testing AGAIN.
but the chart says bullish.
This thing is looking very wobbly.
But with the fundamentals it should be looking wobbly.
Company wants to submit another denovo which will be denied without human testing. That way they can drive the share price up and dump before the denial PR and say "people were tired of waiting ".
Radiogel isn't a denovo product it's class 3 high risk and will definitely need clinical trials.
Jim left enough room for selling a lot of shares in the future. ...2 billion becoming 700 thousand. Radiogel has a chance at approval in 2020-2021 after the share structure will be maxed out again after the 1-3,000 split.
Email from the state agency posted earlier today or last nite on the board says it was updated August 2015 - after denovo denial.
https://www.lsdfa.org/profiles/fisher2
Evil.. if you haven't seen this link ...was updated August 2015
The information available from a current government listing contradicts your prediction and is confirmed with the email they sent which is posted on the board.
Human testing is wanted by the fda ...
Maybe it's not "requested " - its all in the wording here.
Ive applied for official documents in compliance with public disclosure laws. Should have the results this week or next week. Will share those results to help clear up any confusion.
Fda will not pass radiogel with no predicate device without human testing. Thank god our fda is so cautious.
And yes radiogel "can" be submitted again with only animal testing but it will be denied again for sure.
Denovo is not for radiogel. Radiogel is class 3 high risk.
It seems some "investors" are trying a little TOO hard to shoot down the human testing thing. A little TOO HARD.
Hhhhmmmmm......
Human testing is obviously in the paperwork somewhere.
Oh yeah at the fda meeting PR he says we have a clear picture of what the fda wants. But thats all it says.
Not too hard to add it all up with all these pieces to the puzzle.
Radiogel "CAN" be submitted to the fda via denovo with no human testing. It will be denied again gauranteed.
If radiogel ever has a chance of getting fda approval it would have to have human testing. Its a no brainer. There's no predicate device like the other y90 products so even if some of those didn't need clinical trials this will.
With all the smoke and mirrors going on and jim wording EVERYTHING like a lawyer and beyond vague the pieces to the puzzle all fit together. A state agency listed the fda wants human clinical trials.
The writing is on the wall.
Which differs from a government posting. The government posting is not a typo.
" The FDA has recommended further animal studies to demonstrate both safety and efficacy, and has also suggested a human clinical trial."
--LSDF 2015 POST DENIAL.
Its definitely current as confirmed in the email. That was put on the website in AUGUST 2015. after fda denovo denial.
Lol...
Website diclaimer. Good one.
Guess you must agree that its a state agency now. Unless the disclaimer covers that too.
Human trials coming. After another failed denovo with only animal testing of course.
Its pretty obvious there's some funny business going on here.
Like i said typing JUAT instead of JUST is a typo.
The words HUMAN CLINICAL TRIALS is not a typo.
Are you saying its a typo on the state agency's website?
You're wrong. Heres a quote from their site.
" As a Washington state agency, the Life Sciences Discovery Fund (LSDF) must comply with the Washington State Public Records Act RCW 42.56. More information on LSDF practices regarding public disclosure may be found in, "LSDF Grant Application Information-Public Disclosure."
https://www.lsdfa.org/lsdf/disclosure
I applied for the documents in accordance with the public disclosure laws for the state of Washington.
I will share my results with the board.
http://access.wa.gov/agency
Heres a list of WASHINGTON STATE AGENCIES.
LSDF is listed on their along with other agencies like ARMY NATIONAL GAURD AND DEPARTMENT OF HEALTH.
Theres no positive way to spin this. Human testing is in the paperwork this update is from AUGUST 2015.
Recommend and suggested. ...same difference. ..
But yes jim is going on exact wording now.
Its obvious that human testing is in the paperwork. ...
The lsdf didnt make a typo in report.
A typo is typing JUAT instead or JUST ...
YOU DONT WRITE HUMAN CLINICAL TRIALS BY TYPO ON A GOVERNMENT WEBSITE.
Nobody said you HAVE to ....
But it juat sounds like a PR from jim
"We know what the fda wants but we wont tell you."
Same as
I HAVE INFORMATION FROM ANOTHER SOURCE BUT WONT TELL YOU. ...
i would think there's no reason to hide your DD source or is there?
Nice try?
That seems odd to me for an investor. You said you had information from an unknown source i just asked to provide your information thats what goes on here....nice try seems odd.
What sources are you referring to? If its a good credible source please share.
If you have any documentation or links please provide to support your prediction.
The only prediction thats currently provable is that human test will indeed be needed. This is shown on a government link.
AMIC can submit another denovo but thats not reality.
Until someone provides proof otherwise it appears human testing will be needed as shown in a quote from a government agency.
If you have that proof please provide it.
I applied for the document straight from the government. Will post those results from the government when i recieve them.
If fda approval is "anticipated " thats probably going to be 2020 or longer and even though the balance sheet got patched up a little that wont help after the company turns 2 billion shares into 700 thousand. Then the dilution after the RS will kick in. There's HUGE HUGE room for dilution now.
Theres no chance of denovo for radiogel. If it gets submitted denovo again thats just wrong.
Maybe fingers are being pointed in the wrong direction. Certain investors in AMIC say whatever to keep things looking good.
Ive applied with the government for the documents through public disclosure laws. I will post the results straight from the government.
Well the statement you said has a big difference. Jim has never said human testing is not needed.
He did say "if the fda asks for a human clinical trial we're ready" never said no human testing required. Big difference.
It's obvious its trying to be hidden. But its too late now cats outta the bag.
Ive applied with the government for the documents through public disclosure laws. I will share the information i recieve with the board.