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When this gets approved and we all make some serious cash..
I have another one in the wings that is very under the radar
beer money type of deal the ROI if they get the science right
is staggering to say the least. just remind me in a few weeks
after we rake in here.. Do I sound a little cocky. yep..
It is what I do for a hobby. find these stocks that are
hated by the market for one reason or another. dig around
the science and the people involved both for and not.
Then make a call .. I look for a .60C on the day FDA does the
conditional go ahead. Then 2 buck when the current trial is
in, that I pointed out some time ago. from there who knows.
time will
Tell
Pilot
Three weeks and a few days Shell ..
There is a super beer money play.
If you got it and can loose it and not worry about it.
It could be worth your time.
There is one of those crazy plays that can change lives
on a single day of trading. Lots of eyes and ears
on this. Take some time to research it out.
I think you have a team that can help you a bit.
I found some quality here and took a solid position
based on our research and have more in the wings
that I can chase to a point if the FDA sees value.
Pilot
Not sure in line with my research.
I have been bullish since the FDA meeting did not
even know of this stock prior to it. Just thought it was
unique it was trading during the meeting last month.
And then got to looking around found some information that
I posted up and then dug around some more.
Pilot
Astute you are my friend. Yes I think there is some lurking in
the shadows. This is not for the swamp btw.. OK.. There is something to this science. The FDA can not figure it out OK..
They are under the gun.. The media picked up on the meeting last month. Small groups but then there was some other reporters who
caught wind of this thing. I think now there is now a heavy pressure on the "poss Death Panel" image the FDA has to prevent..
The speakers and members of those who are for this drug are not the run of the mill oh whow is me type. .But filled with professional grade people who are suffering who know in their heart that this med is doing something right. They don't know what it is either. But someone does. Some group has to have figure it out or is close to it. They want this firm. Watch.
Of course this is IS SPECULATION on my part. But that is the name of this game.. time will tell
Pilot
Like I said I lost it over there .. sorry man
Got mine today also Bob has the vision I spoke of a very long time ago and he is going for it. I am now in cruise mode with this. If I could tell Bob one thing it would be thank your for opening your mind and heart to some of the crazy ideas that come from those of us here on this board. They are paying off and fit like a glove into your overall vision. Well done sir...
yeah that is what I would say.
Pilot
no the yahooooswampfestboard.
Just stepped in Still here just watching very comfortable with
my research and speculation.
HEB flashed a card last week for those who were paying attention.. Someone in the swamp saw it and brought it up
it got sent down the line by short traders and the bash gang.
I commented real quick then lost the post info.
Sorry but the savvy among you here can find it and chew it over...
Have a good weekend
PIlot
More than you know... IMHO
Like button pushed. :)
A very good move,
The HAPIfork, which won CES' Innovations Design and Engineering Award, is part of a suite of other HAPI-health products, including an activity tracker and a watch that monitors stress levels and sleep.
......>>>
As time progresses in the medical connective health area..
We have seen and are seeing such innovation/s that are keeping the individual informed of what their body is doing during the day. I have been watching this kind of thing for over two years.
A lot of the tools are direct medical issue tools such as diabetic tools that track and send info to the user and doctor if needed. But the area that is going to be huge is the progressive health minded individual who wants to track where they have been how many lbs lost what food was taken in. etc..
Then the next level I am seeing is a group competition via Social media. Watch your Facebook pages for the runners you know who are posting the miles they ran and the track they ran..
I have a few buds who are battling it out to see who gets the most miles per week.. Now take that a step further. People can get a base line physical info put into there tracker. And as they work out and start living a more healthy life style these applications can track the result. They have a nano sniffer for your breath and O2 count and chemical output on fast track over at Ames research. There are a ton of them.. And all of them can connect to the MMRG offering if they contact MMRG.. So I say Yeah Bob.. YOUR Again are on the Right Track..
Pilot
Hey those of you that subscribe, And have not visited the mymedicalrecords.com site in a while
. check out the fax on 11/20/2012
It is a game to play. learn about the benefits of Probiotics!
I really need to visit the site more often.. I plan on downloading it and playing has anyone else down loaded yet??
Humm good idea.
Pilot
There is no way that it took you this long to discover this connection, EZ2.. But yes the one and the same line.
Healthcare Holdings Group, Inc. (HCH) extends patent infringement protection to its customer-base through a recently signed nonexclusive Patent License Agreement with MyMedicalRecords, Inc. a wholly-owned subsidiary of MMRGlobal (OTC: MMRF). Established in the Personal Health Records (PHR) market with AccessMyRecords.com since 2005, HCH breaks into the Electronic Health Records (EHR) market with MU compliance and customer-base protection as a guiding force for their HIMSS13 multi-product launch–the highly anticipated release of ChartZoneMD EHR Software Suite for General Practitioners and Chiropractic disciplines.
“Industry standards are an integral part to the successful implementation, trust, and public acceptance of HIE [Health Information Exchange] and related markets. In recognition of MMR’s recent patent approvals–specific to providing online medical records–we feel the investment towards compliance is a responsible protective measure with direct benefit to our clients and shareholders,” said Leonard Tambasco, Chairman and CEO of Healthcare Holdings Group, Inc. Of the nonexclusive Patent License Agreement with MMR, Mr. Tambasco said, “This Agreement solidifies HCH’s position to enhance and continually support industry-wide standardization efforts.”
According to Robert H. Lorsch, Chairman and CEO, MMRGlobal “HCH customer agreements warrant and represent that they have all necessary rights to offer their products and services. This Agreement demonstrates that HCH takes that representation seriously by acquiring the necessary Intellectual Property rights to protect their customers.”
An additional market advantage unique to Healthcare Holdings Group, Inc. is their product line’s ability to provide doctors and clinicians with a series of free-standing or add-on modules–like their Patient Portal or SmartFormsMD Voice-Command Module with Medical Dictionary–to be used with other EHR software environments. HCH will launch their MU compliant EHR at HIMSS13.
About MMRGlobal, Inc.
MMRGlobal, Inc., through its wholly-owned operating subsidiary, MyMedicalRecords, Inc., provides secure and easy-to-use online Personal Health Records (“PHRs”) and electronic safe deposit box storage solutions, serving consumers, healthcare professionals, employers, insurance companies, financial institutions, and professional organizations and affinity groups. The MyMedicalRecords PHR enables individuals and families to access their medical records and other important documents, such as birth certificates, passports, insurance policies and wills, anytime from anywhere using the Internet. MyMedicalRecords is built on proprietary, patented technologies to allow documents, images and voicemail messages to be transmitted and stored in the system using a variety of methods, including fax, phone, or file upload without relying on any specific electronic medical record platform to populate a user’s account. The Company’s professional offering, MMRPro, is designed to give physicians’ offices an easy and cost-effective solution to digitizing paper-based medical records and sharing them with patients in real time through an integrated patient portal. Through its merger with Favrille, Inc. in January 2009, the Company acquired intellectual property biotech assets that include anti-CD20 antibodies and data and samples from its FavId(TM)/Specifid(TM) vaccine clinical trials for the treatment of B-Cell Non-Hodgkin’s lymphoma. To learn more about MMRGlobal, Inc. visit http://www.mmrglobal.com. View demos and video tutorials of the Company’s products and services at http://www.mmrtheater.com.
About Healthcare Holdings Group, Inc.
Healthcare Holdings Group, Inc. (HCH) through its wholly-owned operating subsidiary, Access My Records Inc. and related Personal Health Record (PHR) product line AccessMyRecords.com (AMR), provides its members with a secure and easy-to-use online health record management service with benefits to multiple consumer and business markets. The AccessMyRecords.com cloud-based PHR facilitates the Health Information Exchange (HIE) component compliance for employers–enables both individuals and families to access, upload, or retrieve their medical records and other important documents, anytime using the Internet or a Smartphone. AccessMyRecords.com is built on proprietary technologies and facilitates bi-directional communication featured in its free-standing Patient Portal. ChartZoneMD EHR Software Suite is HCH’s newest multi-featured product line designed to give General Practitioners and Chiropractic disciplines an easy and cost-effective cloud-based practice management solution. The comprehensive suite of applications and tools allow clinicians to seamlessly shift from paper charts to the recently mandated Meaningful Use EHR format and audit-reporting styles. In addition, HCH has developed SmartFormsMD, a free-standing voice-command module complete with medical dictionary integration, specialty accommodation, and a host of customizable options. The ChartZoneMD Software Suite enables real-time sharing of medical records with patients, via the AMR integrated patient-portal module. Both AMR and SmartFormsMD are adaptable software modules to any 3rd Party EHR.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature, including statements about future performance, expectations, beliefs, intentions, estimates or projections, constitute “forward-looking statements.” Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Healthcare Holdings Group, Inc.’s actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. Some can be identified by the use of words (and their derivations) such as “need,” “possibility,” “offer,” “development,” “if,” “negotiate,” “when,” “begun,” “believe,” “achieve,” “will,” “estimate,” “expect,” “project,” “maintain,” “plan,” and “continue,” or the negative of these words. Factors that could cause or contribute to such differences include, but are not limited to, the risk our products and services are not adopted or viewed favorably by the healthcare community and retail market, both in the U.S. and internationally; risks related to the current uncertainty and instability in financial and lending markets, including global economic uncertainties; product integration in physician practices and hospitals; timing and volume of sales and installations; length of sales cycles and the installation process; market acceptance of new product introductions; scheduling; ability to establish and maintain strategic relationships; ability to identify and integrate acquisitions; relationships with licensees; competitive product offerings and promotions; changes in government laws and regulations and future changes in tax legislation and initiatives in the healthcare industry both in the U.S. and internationally; undetected errors in our products; possibility of interruption at our data centers; risks related to third party vendors; risks related to obtaining and integrating third-party licensed technology; acceptance of the Company’s marketing and promotional campaigns; risks related to a security breach by third parties; maintaining, developing, exploiting and defending our intellectual property rights including those pertaining uncertainties associated with doing business internationally across borders and territories; and additional risks inherent in development stage businesses. Healthcare Holdings Group, Inc. is providing this information as of the date of this release and, except as required by law, does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.
Contact:
Investor Relations:
Mr. Lenny Tambasco, CEO
info@healthcareholdingsgroup.com
http://www.healthcareholdingsgroup.com
From the many years studying Bob and Company..
If indeed he rolls up his sleeves and goes after one of the firms
that are listed in your post. I have no doubt mmrg will succeed..
I have taken a lot of time to read and reread the patents and one of the firms is sitting like a deer in the headlights. And down here they are good as dinner on the table.
Pilot
What will be nice to see now is about 6 months from now when all that paper is gone and it is all no a pro. whoop whoop
Thanks for the quick reply ,, I do doubt there is anything the sec can do but I am pretty sure that there is some unanswered questions about how all this went down. And If indeed someone was willing to do the footwork to discover if the current firm who holds a product that looks on the surface to be the same this firm use to market .. Then to me there is reason to think that there were actions that were taken either prior or after the bk that the BK Judge was not aware of. I don't have enough in this to even worry about it. But if others do it may be worth their time and effort to follow up on this line of thought.
Do you or anyone else on who use to hold this or are still holding this have any pictures or accounts of the GPS golf
tracker the firm held??
My reason is that there is another product that looks very much
the same on the market and if indeed this is the same product
that might of been sold for a profit by this firm. I feel the SEC should get as much info that we can gather on this..
who knows. maybe there is something the SEC can do about this firm..
Pilot
Of course Three you have a ready made team of VAR's sitting right here. If the price is right poss residual ??
just saying.
Congrats Three I do hope it all works out well for you.
http://www.mmrracehorsephr.com/
good job.
Not often you and I agree. I am sure Bob is aware of his facebook page is a way to inform the public.. He has posted information there so that is fine. It does amaze me the to da moon and were going to be rich post that hit this board.
The fact is this firm is on a steady uphill climb. a day in and day out grind to make it happen. I am very pleased with the progress of MMRG in all areas of it's efforts.
The upside of this effort can be very nice for all involved.
But it is an effort,work,though,planning and as Bob said thinking outside of the box.
That thinking outside of the box has given this firm a upper hand and I hope to see the bottom line of that upper hand in the 10K and 10Q coming in 2013. With post on FB like today
there should be evidence on the next couple of Qs.
Till then my champagne is on ice.
Pilot
First this is Speculation, what I call SWAG or Scientific Wild
A*^% Guess. Keep that in mind please ...(also feel free to ask me any questions on this I will try to answer, But please do not Flame me. I will put you on iggy in a heartbeat.)
I have found that there is no easy answers in investing if there was there would be no market. But concerning HEB I have found some things that have not been discussed or brought out on the boards to be considered.
First we all know the Panel split the call and the feeling coming out of the meeting was they needed more research as
HEB had done a "sloppy" job. Well that is there point of view and I respect that. But it did put a question mark in my head.
When the Government says something is sloppy to me that is the kettle call the pot black. I also had the impression that the whole meeting was more of a staged act verses a meeting of the minds to try to come to a solid information and goal setting meeting. What struck me also was the feedback from the public,
their plight and passion tore my heart out. This combination
of factors is what kept me around to look a little deeper.
First off my deepest heart felt prayers go to those who
have had to deal with CFS in their lives. The outright misunderstanding for years from the Government,Medical community, Media, and General Public is very sad indeed.
It was not until not so long ago that this was thought to be
just a mental issue. A mental mind game by those who were involved. A feeling that those who had this were just as the name hints to, a lazy group of people. But due to the work of HEB and other science they discovered that there is an underlying issue in the chemistry of the body that is the root cause of this disorder. It was not until April 21, 2011, at a town hall meeting in Reno, NV, local resident Courtney Miller asked President Obama for help.
Obama has designated his deputy chief of staff for policy, Nancy-Ann DeParle, as his point person for dealing with the disease and to work with the National Institutes of Health.
The president has asked DeParle to convey a sense of urgency about CFS and to raise its standing.
From this sense of urgency I feel is why HEB and Ampligen was brought back to the table.
September 13, 2012,
http://www.fda.gov/downloads/Drugs/NewsEvents/UCM320310.pdf
NWX-HHS FDA CDER (US) Go read this again if you have not.
Notes:
_____________________________________________________
Dr. Sandra Kweder:
(Deputy Director of what's called the Office of New Drugs.
And the Office of New Drugs at FDA has 18 clinical - clinically related review divisions within it.)
"But I think - but your point's a good one. And I'll sort of respond to a couple things that you mentioned. We consider
your condition to be in the category of serious or life threatening diseases."
"It's really different than if the doctor thinks the patient does better. You want to know does the patient think the patient's better and be able to measure that well and reliably so that if the drug works we can figure out very quickly."
"One of the things that we've learned from experience is you've got to be able to define the condition well and /they\(note
firms that study conditions) need to - they want to know where are the rules about studying it. What am I going to have to
show in order to get a drug approved? Because I don't want to invest in a drug that I'm ultimately not going to get
approved for marketing. That's not good business for me."
"And that is really one of the fundamental precepts of all of our expedited programs such as accelerated approval and
expanded access of drugs under investigation. That is a promise of the program that patients with serious conditions are willing to accept more risk than patients with conditions that are not serious. So you can be assured on that."
"With regard to our credibility at approving something, this really gets back to the heart of what is FDA's usual role.
We can only approve drugs where we have an application that is submitted to us for approval. That's the law. We can't just
pull up a drug and say, "We think this works and we're going to go ahead and approve it." We need data and today the only
application we have seen seeking approval for either ME or CFS is Ampligen."
"We often use, you know, subtypes or subgroups of people in clinical trials to really try to identify, you know, smaller
number of patients, the effect of a particular drug.
That's where, if I was to issue a guidance document for industry on enriched clinical trials, it's called Enrichment
Guidelines,(note study up on this) how to do those enriched clinical studies so that you get to expose less people for a shorter period of time to get your answer. So that is something that we think about a lot from multiple conditions and, you know, we're open to the idea that this may be one of them."
____________________________________________________///
Technology such as the body BodyBugg or the FitBit are ways that you can actually physically measure the activity of the
patient before and after treatment. (this person hit a very important point. How the patinet is reacting
to treatment.!!)(I would like to look further into the tech side of measurement from an outside product that is
directly sent to a online data center, the reason it that the FDA test could use this info tacked into a
Big Data Algo as a reliable measurment.)
Take time to re-read Justin Reilly Comments. "I've noted there's some Harvard graduates there, law professors. So through patient community, who's been around - I've had ME for 10 years. I'm one of the younger ones here who's involved. You
know, the ones who have had this for decades have been studying this disease for decades. And so,they're more knowledgeable than most of the MD's out there."
_______________________________///
CDC website info..
http://www.cdc.gov/cfs/general/index.html
Note this
http://www.cdc.gov/cfs/general/index.html
The study started in 2012 and aims to enroll 450 patients.
Note the Clinics,
Pain and Fatigue Study Center, NY
Center for Neuro-Immune Disorders, FL
Open Medicine Institute (OMI) consortium:
Open Medicine Clinic, CA
Sierra International Medicine Associates, NV
Fatigue Consultation Clinic, UT
Hunter-Hopkins Center, NC
Richard Podell Clinic, NJ
Now go look back at the past Hemispherx's Ampligen Trials and see how many of the above clinics you can match up..
The Twentieth Meeting of
THE CHRONIC FATIGUE SYNDROME ADVISORY COMMITTEE
US DEPARTMENT OF HEALTH AND HUMAN SERVICES..
Tuesday, May 10, 2011
http://www.hhs.gov/advcomcfs/meetings/minutes/cfsac-meeting-minutes_20110510.pdf
"Thought the CFS case definition was a barrier to success and we need standardized data elements and outcome measures. Thought existing resources for data sharing and clinical networks must be leveraged."____
____
And so there you go there is indeed ongoing clinical developments. We see from the above that there is upper level government attachment. We see that there is funds coming in
from the government to really dig deeper into this condition.
We see there are is a pool of patients who have the knowledge that Ampligen helped them. We see they have been neglected by the FDA for some time, But at last the FDA/CDC and others in the Government has taken note and are taking action.
We heard the conclusion of the Panel, the one yes vote was safety related. That Vote to me moves this Ampligen to one of the next phases or the Government CDC trial as noted above.
But within the confines of a structure that demands rigor of scientific method. So in conclusion I think Hemispherx's Ampligen,gets a pass to move forward with some serious conditions on how they conduct each and every step.
I feel that the investment community needs to step up
and show the Pharma firms we have in desire to see this CFS
meet head on and if that means running this stock to a couple of bucks on huge demand, even with all the issues they face.
Then so be it. The only way to show the government and big pharma that this condition is worth their time and money, is
to show that the investing public is willing to take a risk.
Just as those who have this condition are willing to take a risk by entering into clinical trails.
Well that is about it.
I do now hold shares in HEB, I am not a Doctor. (rub dirt on it it will be better) I am not in investment pro, actually I am just another person on a chat board giving my thoughts to anyone who is willing to read.
Best of luck to you in all your investments.
To anyone who has the CFS I am so glad that the Government/FDA/CDC. has become active in your plight.
I wish you all the grace to hold firm and find the answers
your looking for. God Bless..
Pilot
Actually kinda in my own sphere.
Time is just an illusion to me when I get to
chasing wabbits. I got a good track and have been
tracking it down. put up a couple of hints.
But now am working on how I want to position
myself. anyone can find the info on the net
just takes time and effort. ///
Pilot.
$100k combined in those larger blocks.
Proof that DPDW buying is very likely.
jstsaying.
Question if you just put out near a half a million
into research and were the government would you like
to kinda save face by saying you needed more research.
I think so.
More to come
Pilot
Just something to watch to help you understand your own research.
http://vidgrids.com/fda-approvals
And just because I need a quick notepad.
type in Ampligen on this PDF..
Wonder how this is going.
http://www.questpharmatech.com/pdfs/Quest%202011%20MDA.pdf
Pretty much to the point.
http://www.hemispherx.net/content/investor/corp_governance.htm
Information contained on the Hemispherx website other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risks of competition, changing market conditions, changes in laws and regulations affecting these industries and numerous other factors discussed on the Hemispherx website and in the Company's filings with the Securities and Exchange Commission. Accordingly, actual results may differ materially from those in any forward-looking statements. Additionally, all the referenced investigational drugs and associated technologies of the company are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgement as of the date of this website. The Company disclaims, however, any intent or obligation to update these forward-looking statements.
LOL , I hear you..
Should of put a patent on the concept. Oh well here you go..
http://www.businesswire.com/news/home/20121221005822/en/Doctor-Now%E2%80%A6On-Computer
-Anthem Blue Cross members will soon have a more convenient way to see a doctor for non-emergency needs when their own doctor is not readily available.
Xan Thank you will do when I get up that way.. On watch on the Coast right this moment..
God Bless
Pilot
Ok this is just funny
http://www.avonhypnotherapy.co.uk/chronic_fatigue_syndrome_CFS.htm
or sad depending on how you look at it..
But wonder if I could use that for my stock trading..
cross fingers sit cross legged and go hummm or thirty min a day.
you will become an expert stock picker.
I don't know about that but I love your avatar. ..
here is a bit more for you..
"There's probably a subgroup where this works," Gailen Marshall, MD, PhD, medical professor at the University of Mississippi Medical Center, said. "It's just not for everyone."
"What we need is two studies that have adequate sample size and the same endpoint," said Irwin Russell, MD, PhD, director of fibromyalgia research at the Arthritis & Osteoporosis Center of South Texas in San Antonio.
Panel members were heavily swayed by nearly 2 hours of compelling patient testimony from patients during the meeting's public hearing portion. Even panelists who voted no said they didn't want to keep the drug from patients who might be helped, although it might be just a small group.
Hemispherx officials said they believe the safety issues the FDA raised -- for the first time in nearly 20 years of development -- are unfounded and could be resolved by a more thorough review of its data.
"We would be pleased to sit down with the FDA reviewers to discuss these issues," Hemispherx Chief Executive William Carter said Thursday.
Hemispherx said the FDA counted single adverse events as multiple ones, and also counted benign tumors and malignancies. The drugmaker also said there was no increased risk of death or suicide from the drug. The FDA noted three deaths, two of them suicides.
One patient had a lupus flare, which the FDA counted as an adverse event. The drugmaker said the patient had lupus before the trial started, but having that condition should have disqualified the patient from participating.
The above David Pittman is MedPage Today’s Washington Correspondent,
(((Side note.. Big Data Analytics is on the rise it is becoming
a lot more easy to do this kind of thing. I hope HEB has someone looking into the really great frims that are popping up all over the net. ))))
Here is more info from across the web..
Alaine Perry, who served as a patient representative on the advisory committee, acknowledged that the Ampligen data are slim, but noted that CFS symptoms can be so severe that some patients would willingly take on a significant mortality risk for the promise of even minor relief of their symptoms. “A very small improvement in a disease like this is life altering,” she said. There are no other approved treatments specifically for CFS.
But if you really want the kicker the reason the down and dirty..
http://www.cdc.gov/cfs/programs/clinical-assessment/index.html
you got it CDC is stepping in had stepped in is going to help.
I think HEB new this from the get go but had to get on the record
the data so it could be included in the data also. This CFS is not by far a lost cause neither is HEB....
This is why I knew I had see this somewhere just had to dig it out..
February 2013 (final data collection date for primary outcome measure)
Seems like someone was planning ahead....
http://clinicaltrials.gov/ct2/show/record/NCT00215813?term=NCT00215813&rank=1
Endpoint Classification: Safety/Efficacy Study
What was the panel looking for>?? Safety and EFFICACY Right??
Now take the FDA date most folks are looking for what FEB 3 or the such. from the panel.
Add in this final data and put those together and start to see a picture.
But really my job keeps me away from home for a month at a time
and it landed this year that I get to be away for Christmas and New Year. Sigh:( but that is ok it is part of life that I chose and
it's rewards are well worth the time and effort.
Merry Christmas hope you all have a great time with your Family and loved ones. Well me I am on the boat. whoopie.
Anyway quick question did the Faville stuff have
bispecific antibodies ?? just wondering.
Thanks..
Pilot
$HEB,
Folks just don't know what to think they read the message boards
and see partial truths and outright lies. The only way to be
successful with this is to take time to read the studies.
The panel information and the science behind this.
It is a unique array that is why the FDA is wanting to make
darn sure it was safe. We saw the vote.. It is looking good
on that. Now they want to see if it is effective.
Some say it is some say it is not. The Panel wants more info..
The info is there.. I just was not given to them in a way that pleases them .. . So this goes into the pizzing match phase.
Which is ok. The panel and the FDA really understand that
people are taking their lives because of this CFS. And that alone
with the safety vote, is enough to raise some serious concerns
on how to proceed imho. If the FDA shoots this down, I doubt
HEB will continue to even mess with it. You could hear the frustration from the HEB rep at the end of the meeting.
The panel is worried about a decreased white blood count
and a single monkey that had a blood clot. And HEB is concerned
about people who will have no hope for a cure. who just might
take their own lives due to political paperwork issues.
FDA has a really big opportunity to help people with CFS.
they can not ignore the 30 some odd public comments from those
who spoke to the panel, Some with some serious pedigree attached to their names. This is well worth the time and effort from both HEB and the FDA. Do I sing all good things for HEB and their methods. NOPE nada not a bit... They needed to have their collective tails chewed for the way they presented their findings.
Any high school kid in science class has at least a understanding of the Scientific Method. The step by step proving of a theory. Why were some of the steps not taken or changed without documentation. That lands right on HEBs doorstep and good for the panel for making it an issue. But the panel wants to move forward and so does the FDA and so does HEB as proven with the link of the continued study and trials.. That were not spoken of.
time will tell .. I hold out a pretty good glimmer of hope for those people with CFS and I think the FDA does also.
Pilot
Stunned some shorts last week will happen again soon.
Just some notes and thoughts.
In June 2012, DPARP
held a Type A meeting with the sponsor to discuss the stalled development program. In this
meeting, the Agency noted the following:
You propose new post-hoc analyses of data from Trial 516 and a post-marketing
trial (AMP-520) to support approval. It would be unusual for this type of data to
provide adequate evidence of efficacy. However, the adequacy of the data will
ultimately be a review issue, and it is reasonable for you to submit a complete
response. This complete response needs to address all of the issues defined in the
complete response letter dated November 25, 2009. As Ampligen is a new molecular
entity, we anticipate that the data submitted in your NDA would be presented at a
public Advisory Committee meeting… The standards for approval require the same
evidence of efficacy and safety, regardless of approval pathway.
The sponsor has not conducted carcinogenicity studies, which was cited
as a deficiency in the first review cycle.
(DNA is nucleophilic, therefore soluble carbon electrophiles are carcinogenic, because DNA attacks them.)
(A nucleophile is a chemical species that donates an electron-pair to an electrophile to form a chemical bond in a reaction. All molecules or ions with a free pair of electrons or at least one pi bond can act as nucleophiles.)
The most commonly observed effects were apparent acute phase
inflammatory responses (fever, leukopenia, lymphopenia and neutrophilia) following
Ampligen administration.
(leukopenia is a decrease in the number of white blood cells (leukocytes) found in the blood, which places individuals at increased risk of infection.)
(lymphopenia Lymphocytopenia, or lymphopenia, is the condition of having an abnormally low level of lymphocytes in the blood)
(Neutrophilia (or neutrophil leukocytosis) describes a high number of neutrophil granulocytes in blood)
(Neutrophil granulocytes are the most abundant type of white blood cells in mammals and form an essential part of the innate immune system)
An incidence of mural thrombus in the lung was observed in one female
rat treated with Ampligen.
Based on this analysis, the trial was stopped with 92
completed patients. Patients were required to have a diagnosis of CFS for one year or
longer according to the 1988 CDC criteria and reduced quality of life as defined by a KPS
score of 20-60. The primary endpoint for the trial was improvement in KPS with ETT
duration as a secondary endpoint. Each patient’s KPS was evaluated every week, and a
derived variable was determined at 4 week intervals by taking the mean or median of 4
observations (i.e. Week 24 KPS values were obtained from Weeks 21, 22, 23, and 24). Of
note, the exercise protocol was changed from a Bruce protocol to an easier gradation after
the first 7 patients because patients were having difficulty completing it. There were no
corrections for multiplicity (Type I error) for the secondary endpoints.
(Well go figure look at the protocol.