Is it going to be a public hearing or just a letter.
Or do you know.

Celgene CELG 2/10/2013 FDA Decision (NDA) Pomalidomide

That was the Logic I thought the FDA was going to use.
But as of now they have set a defined 3 step process and
drawn the line in the sand .. All my speculation and research is
toast. There is no reason this should not of gone that way.
And now with it in writing and people selling out of the stock
FDA has to stand by it..

It was the tone of the FDA. that has me concerned.
It was like drawing a line in the sand.
Stupid for sure where so many lives are concerned but
I doubt HEB is going to be able to afford any more research.

Just found this the source is pretty solid as she was at the hearing. This does not bode well darn it.
This statement is what stood out.
"allowing the company an opportunity to correct those clearly defined deficiencies in a re-submission." As many of you know I have been a strong supporter of a chance for HEB to step up. But the question is can they. will they. I wonder if they even have the resources to step up.

Feb 04, 2013


Hemispherx announces receipt of a Complete Response letter for Ampligen to treat CFS


Q: Why did Ampligen receive another Complete Response (CR) letter?

A: On February 4, 2013, Hemispherx announced the receipt of a CR letter from the FDA for Ampligen. FDA issues a CR letter to convey that our review of an application is complete and we cannot approve the application in its present form. A CR letter describes all of the specific deficiencies that the Agency has identified in an application, allowing the company an opportunity to correct those clearly defined deficiencies in a re-submission. Because the NDA for Ampligen is not approved, FDA cannot provide information or comment about what was contained in the CR letter unless Hemispherx makes that information public.

Q: What treatment options are currently available to treat ME/CFS?

A: There are currently no FDA approved treatment options for ME/CFS. According to the CDC, managing chronic fatigue syndrome can be as complex as the illness itself. There is no cure, and symptoms can vary over time. Thus, people with CFS should closely monitor their health and let their doctor know of any changes; and doctors should regularly monitor their patients' conditions and change treatment strategies as needed.

Q: Where can I get more information on Ampligen?

A: Please contact Hemispherx for more information.

Q: Does FDA consider ME/CFS to be a serious disease and what is FDA doing to aid those suffering from this disease?

A: Yes. FDA considers ME/CFS to be a serious disease and we are and will continue to be active participants in the search for effective therapies for persons with ME/CFS. The CR letter issued for Ampligen is entirely separate from FDA's support of drug development pathways for CFS.

In support of the ME/CFS community’s needs, FDA is an active member of the Chronic Fatigue Syndrome Advisory Committee, which provides advice and recommendations to the Secretary of Health and Human Services (HHS) on issues related to ME/CFC. In 2012, FDA held a stakeholder teleconference and a November webinar titled “Myalgic Encephalomyelitis and Chronic Fatigue Syndrome: Working Together for Change.” Future plans include an FDA sponsored workshop in spring 2013 focused specifically on ME/CFS drug development.

FDA encourages the pharmaceutical industry to continue to look for new treatments in this area.

It could indeed but as of this second I am seeing blood in the john. Not good but hey I have partied with the rock stars.
What's a little blood when the beer is flowing. Ouch this is going to be very difficult for a lot of "investors" this morning. Heck the next few weeks. And even harder on those with CFS. Crazy stupid on a lot of folks part who should of just done the science line by line. Now they have something that is working and they can not prove it. Whow just Whow

Three steps to Approval..
Hemispherx should conduct at least(1) one additional clinical trial,(2) complete various nonclinical studies and (3) perform a number of data analyses.
Hoops upon Hoops frigging FDA and their mindset .
Gawd

Whow, Just Whow..
Now do the patients who had access to the drug no longer have access.?? did the FDA just Paint a bulls eye for the DEATH PANEL. Marker.
Oh the media is going to eat this up. imho.
Is this the end game for Hemispherx. Is my beer money still on the table. Why yes indeed it is. Dragging it out a bit.
But that is the government for you.
I would suggest reading the pr over and over again.
I am pretty sure the will cause a sell off in the morning.
But I still like the science.
Gut check. yes.
Hemispherx is not backing down. And
that is important to me. the CFS community now has some media
attention. And someone is buying this stock like no they are
either very smart of very stupid. and not just a little bit.
Reminder to self. .Always Always only put money in bio stocks
that I can afford to loose. That is why I always call it beer money.
My plan as now is as it always was. I am sitting on what I have
I have powder in the wings to chase if need be. If after all is said and done this firm fails outright. I count myself lucky that it is only money and not a life long sickness that leaves me with no hope. Due to the Death Panel ignorance.
Pilot

They are there on the site just have to download it.
Oh and that map tracker did you see that it also
uploads the info. I have not sent that one to bob and
his team yet. but looks like they should be on the list also.

Do you carry the card with you >>> ??

If you don't want mom seeing your records you have to put them into their folders. From what I understand the main section is really an emergency contact info section that doc/emt can get into so they can find basic info that is critical to each member in the family.. ie allergy medical conditions etc.
Then the other folders are password protected again by you the account holder that only you have access to.
So if mom is on that list you get her in the main section and then she has password protect or you depends on your relationship with her i guess.
As for the esafe i don't use that site. as i have that folder in my mmr account already

Down load them to Adobe you have to have an account with them
and they convert them..
not much at all

It is a Dynamic site. Blue. They have so much to offer
it is difficult to navigate. It is an office on a page.
You got not only the phr fax upload, you can fax out,
you can scan items in. you can add notes to those faxes and
scans. You can have the Telemedicine or dynamic real time info
loaded into your account. You can add people pets or what ever to the account, you can lock sub-folders with passwords known only to you.
The way I do it is have the different docs fax stuff in.
Then I drop the medical info into the different kids folder.
Then I beg to get a full billing info faxed and I drop that into the kids folder but also a new folder I call bill/insurance.
And then if I have any questions I download the bill or medical record onto my computer highlight it with adobe in red, upload it back into my account and fax it with notes.. So when I get a grumpy letter from billing I tell them well I faxed you the info on such a date and this is the confirm email I got that you got it. So take that and smoke it in your pipe. That usually shuts them up. It just takes some getting use to.
Can there be improvements .. Sure and as a shareholder I send my ideas in to bob and company as I get them. I figure they will look at it and either say good idea or bad idea and when they update the site then we can all see a better product.

It is a Dynamic site. Blue. They have so much to offer
it is difficult to navigate. It is an office on a page.
You got not only the phr fax upload, you can fax out,
you can scan items in. you can add notes to those faxes and
scans. You can have the Telemedicine or dynamic real time info
loaded into your account. You can add people pets or what ever to the account, you can lock sub-folders with passwords known only to you.
The way I do it is have the different docs fax stuff in.
Then I drop the medical info into the different kids folder.
Then I beg to get a full billing info faxed and I drop that into the kids folder but also a new folder I call bill/insurance.
And then if I have any questions I download the bill or medical record onto my computer highlight it with adobe in red, upload it back into my account and fax it with notes.. So when I get a grumpy letter from billing I tell them well I faxed you the info on such a date and this is the confirm email I got that you got it. So take that and smoke it in your pipe. That usually shuts them up. It just takes some getting use to.
Can there be improvements .. Sure and as a shareholder I send my ideas in to bob and company as I get them. I figure they will look at it and either say good idea or bad idea and when they update the site then we can all see a better product.

Glad you brought that up dig just a bit deeper on that website Recon4. It is right in front of your face.

SMF, Let me quote you and Point out some things you just might not understand.. OK

stockmasterflash Member Profile stockmasterflash

Saturday, February 02, 2013 7:50:53 AM
Re: mr_sano post# 55415
Post # of 55425
Large companies are loathe to do that

because when you settle with 1 (patent troll),***(First you have to understand the term(Patent Troll*** THEY make money largely by buying up patents and licensing them to others, But what you need to know is that The Federal Trade Commission has even taken to calling these lawsuit-happy companies "patent assertion entities," or PAEs. And that FTC and the Department of Justice hosted a public forum December 2012 to study the issue more closely. I am sure your aware that the legal firm that Reps MMRG was aware of this PUBLIC FORUM.. RIGHT?? I doubt it.// Then you have to understand that MMRG is not anywhere near a PAE. By the simple fact that they came up with the concept and have a product on the market that is being Used.'that is called practice btw' RIGHTI am also sure your aware of the Clayton Act and the Sherman Act.RIGHTI doubt it the floodgates open for thousands of others.there are not a thousand other medical records firms who hold patents. They have legal departments, in house attorneys for discovery and early court appearances.hey got that right WalGreen does need this What costs MMR tens of thousands and hundreds of thousands,Do your research,You can contact,Ted Ward, at Liner, he is a partner and maybe he can tell you what the word Contingency means the in house team does as part of their everyday jobs. A company like Walgreens only starts paying for trial attorney's as court dates approach. That's a few years from now.Sorry I don't have the time line for the case oh that is right it is not on pacer yet. So I would have to guess neither do you

Also, Walgreens has every incentive in the world to take this to trial and beyond. BEYOND? Absolutely.AND SO DOES MMRGLOBALWalgreens defendant I.E. they are the ones that directly infringes and continues to infringe on the 466 patent// go look it up They'll risk a multi tens of millions judgement against a million dollar settlement.That is a risk WalGreens will just have to take because MMRGlobal has Demanded a Jury Trial. Because on the very SLIM chance they lose at trial years from now, that loss would be appealed.
That is base on your knowledge and from what is see your knowledge is more like speculation based on a desire to manipulate a stock for your own advantage And then another few years will elapse.Ditto on my last MMRF won't likely survive long enough to see the first judgement,They have lasted from 2005 and have more stuff in the pipeline then most can even track down example from the CEO's blog which is public record." February 10th I attend a series of major customer meetings in Pennsylvania and MMR is hosting a dinner for carriers and payers representing more than 100 million lives." let alone last a decade to see it through to appeal.ditto to above That's the reality here.This is the reality here Walgreens will be taken to court and a jury will choose who is right. Just because Walgreens is big does not mean they are right and can wait it out. if you or Walgreens thinks this is the case they no not who they are dealing with Judgements get appealed. settlements are final and precedent setting.Correct

Also, don't underestimate how the climate has changed for patent trolls the past few years.see above your incorrect on your term here. These suits are now recognized as a significant drag on the economy. Walgreens will see significant "friends of the court briefs" from competitors and industry. MMRF will see a lot of bad press describing them as the parasites that they are.
Or Walgreens will see a lot of bad press describing them as patent thieves who attempted to steal a small firms property
Just wait till Walgreens and the Media start publicizing Lorsch's appearances on MoneyTV.I hope they do Pointing out his association with Two time SEC offender, DonB and the numerous offenders and felons that have paraded through his studio. How do you think Operation Mole will play with the general public? Bounties on people's heads?Actually the said Bounty was to help address people who were Liablest, Who caused damage to MMRG and the investors of MMRF by the words the wrote on this board that were just untrue. ROTFL Wait till the SEC starts looking at Lorsch's MMRF convertible debentures. So I am assuming your saying that Bob has done something illegal with your above statement. Would you like to expand on that please. Spell it out so we all can know. // Or is this another attempt to discredit this firm and it's CEO so you can purchase shares at a discount?This suit will draw a lot of attention. Walgreens will likely make sure that does occur.
Ain't seen a word out of Walgreens So far.

It is both Political and a Health issue.
The FDA can not state that this is not a safe drug.
To many people have used it and been just fine.
The there logic to me is just as important.
They just need to redo the darn study with the drug with
better controls. And that is going on now.
So the Conditional Approval path is one of logic.
(and that is scary when thinking of Gov)
So also there Political side of it is yes.
The Label DEATH PANEL will not only be put on the FDA but the
individuals who had down the call.
I would expect to see news of CFS folks laying down on their front laws.
It could get ugly for the FDA and their staff with an outright
reject.

If some will recall I posted a week or so ago that the news was on this, look for the death panel slant on it.
This is the first shot across the bow of the FDA..
There are other networks who are in the wings just wanting to
to the story imho.
Non approval will be a major bloody nose for the FDA and the Obama Admin.
It will then go viral on the net. And there will be protest
in DC and Across the nation about the FDA Death Panel..
Just my take on things.
Conditional Approval is the only direction FDA can go without
having people laying on the front steps and dying.
And this condition is so serious it very well may happen.

They have 21 days to respond.
The patents are listed in the court document.
If have pacer so you can look at the drawing
that goes along with the patent.

Depends on the science that comes from the trials that I posted about back a few weeks ago. Figure there should be journals that will follow the trials., If indeed they can figure out what the hit on the Sub-set then this one is rip for sure. But again it all depends imho on them figuring out what in the world is making the sub-set group respond to the med.
This is a high priority as pointed out by having a direct link to the white house. People are suffering. And not just us regular folks. It crosses all social classes. And that alone is a reason for concern for the Government.
Pilot

YESsss Sir ,,,
this was some of yesterdays action.
now that we have positive proof in pictures of the actual
documents. Well here we go.

6060207
01/31/13 07:21:26 0.34 0.3112 0.34 6060207

Very
Bullish was expecting it on Friday.
Happened on Vrml on a Friday.

Looks to me some folks are not a bit happy they sold their shares and are going to try to blame and point fingers so they can get more cheep. jmho.

To be kinda frank with you Mastertrader.
I really don't need to tell Bob how to run his business.
I have researched him, his methods and his practices
to the ninth degree. I will break it down into 3 words.

Bob Don't Lose.

Don't want to sound rude. Hope you don't take it that way.

This is the only Picture I need.
Scroll Down


Red added by me.
You can find pictures of the principle place of business by
looking at threeflights past posts..

illusions by richard bach, was one of the reasons I looked into this firm back when Bob was talking about the book.
I started reading bach when I was a kid so wanted to see Bobs take on the book. So with that in mind any pictures are in fact
just an illusion from a know reality created and observed and hence shared via a picture. for all of us here to join into said
reality. While it is a good thing for many to see and join into the illusion of reality. Some just do not have the vision to be able to see that reality and need more information to be able to process the illusion into reality.
Pilot

Yes I have been following Dr. Eric for almost a year now on twitter. Hence the reason I have been pushing Bob and MMRG to get ready for the app stage of the medical record keeping.
And guess what Bob heard and guess what what. If a firm has
an app that is going to upload data they just need to contact
mmrg and they have a system ready along the lines of the ALU interface. So mmrg is ready for this next wave. And is on top of it.

PS I hate partial fills. jeesh.

Uncertain times senderos, all across then nation folks just
don't know what to think anymore. few years back people would of put up some beer money and let it ride. now they want fact backed by the government. but such is the market.
only thing a person can do is research and make a best guess
I am guessing it get a limited approval with strict oversight.
time will tell.

Someone is wanting this bad but is unwilling pay to much..
An the beer money investor.

hey you go T
http://www.healthcare-informatics.com/news-item/walgreens-rolls-out-widespread-deployment-ehr

http://www.greenwaymedical.com/ppc/whitepaper/?gclid=CLi_jtGQkLUCFbKiPAodmjkANw

Sure you can take it from here.
But just a little background from you..
WG has been in the hot water over the disposal of medical records in land fills etc. I am pretty sure they were looking for a solution for this when they went online not to long ago.
They had an issue they thought they had it fixed with this GWay .. Pretty sure given the way Bob works they had the opportunity to make a deal with MMRG but alas that must of not come to pass. So now we are sitting on a firm that is at the high end of stock price with a nice market cap. And coming off a sic. Flu season flush with cash and data. They also have been data mining the EHRs and have suite filed for that against them. They had their hand in the cookie Jar all across the board. I question the ethics of taking personal health information and selling it for a profit. So they had an opportunity to do the right thing imho. And now well they are going to get a bloody nose. Bob does not lose..

Feel pretty confident on this issue. Not just because what bob
says, but rather a list of folks who are friends who have been digging into the patents for some time who all come to the same end result. They as a collective see them as solid..
I am sure mmrg would of rather had them as long term customers but apparently that did not work out. And Bob does not loose.

Know you have seen this one but passing it along for new longs
to look at...
http://www.google.com/patents/US6312718

You have figured out the connection,,//
Savvy man you are.
Pilot

Exactly!

Rain while that sounds good on the surface to many of us.
I think it is flawed logic and this is why.
One good lawsuit bounces the pps up. But in the long run
you have lost a customer. Let's say oh some drug store chain
has stepped into this online personal health management sector.
They most likely were sold the idea by some firm who had a
good product and idea. But unknown to the drug store that product
is a direct patent infringement of MMRG. Now MMRG can take them to court and spend a lot of money or have to pay money at the end of the case to our patent law firm. OK. And I am sure your aware of the time involved in a patent case.
But what about another way of looking at the Drug Store and different approach. A note saying hey you might know this but
that new product you put in action some six to eight months ago.
Well hate to tell you but you are in patent infringement of our
patents. So tell you what we don't want to get greedy but we do want to be fair and get our remuneration. So how about we sit down together and work out a fair and long term deal, one that keeps you making a solid profit.. But also rewards us for our effort many years ago. ??
Sure Rain I would love to see a huge pop in the share price
anyone would. But really when the rubber hits the road.
The business plan imho is geared towards long steady growth, built on relationships with many firms. What I call the WallyWorld Principle, One where a lot of small sales equals a huge return and a strong firm not reliant on any one or two customers.
Just my way of seeing things
Pilot

Check your inbox

Yes still very much here. I still owe you a beer so when you come to the bluegrass track at the confluence of two rivers
in my state shoot me an message if I am off the boat I will be in the stands watching then will hand deliver a tall cool one when you win..
Till then I am on cruise mode here the research that was done
a long time ago still stands as a fact that is moving forward.
There are now new dynamics that came from here to the firm that
have increased the long term value.
While your original thought is still here I feel it is being managed in a manner that is acceptable..
In due time that will no longer be an issue and that time I feel
is sooner than many think. Progress is one of the keys that is opening the door to the overall success of this firm.
Based on my basic knowledge on all the factors here this is still very much a value play.
looking forward to seeing you some day//
Pilot

Someone has been doing their research.
Very good info and yes very strong board..

Yes Three you posted some of them last year sometime.
And anyone who doubts that Three would be all over Bob
and his Staff if the office building was not there with them
in it has to really look back a few years. Three is one of
the people who I consider a friend after the fact.
Some of you all may recall a CCall that I was yelling at Three..
But after time I grew to respect him as someone who come heck or high water calls it like he sees it. So if Three says it is such.
I take it as a fact and move on.
But do take pics next week. have em give a big Thumbs up.
Pilot

IB someday will you shoot me your email addy please.
Thanks.
Pilot