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With the case the FDA made? That is highly unlikely to happen. You think they do not discuss this stuff before going into these ADCOM meetings? Of course they do.
I don't have any position here now. But is anyone else desturbed that most of them said there seems to be benefit in the sub group but just did not want to approve it because of technicalities.
This is ridiculous. It works for some people that is undeniable. Another reason why the government needs to get out of our lives. I feel for these people. It should be their decision and their doctors decision to try this medication not the governments.
I would rather bail with profit and the ability to reenter then play blackjack. Not very good odds.
The committee just does not sound very convinced. I think personally they should vote for it. But I do not think it is going to make it. And if it does the FDA does not want it approved on the data provided and the way in which HEB obtained it.
It sad that they are thinking that but lets hope for the best.
I think you all are celebrating way too soon. Could go either way but sounds like more of the committee is leaning towards not wanting to make a mistake. Looks like they are skitish of the information and don't want to be responsible. Disappointing so far.
Well the FDA pretty much just told you what was going to happen. No matter if the advisory committee says yes they will not approve this drug because they have the Code of Federal Regulations backing them.
Still too early to say. The FDA in no way wants a positive vote though. They came right out and accused them of unethical behavior in the trial. My question is why did the FDA staff not report the doctors then for ethics violations?
Seems really crazy, like twilight zone.
Does not look like the culture at the FDA has changed at all. But either way HEB is in deep trouble or the FDA reps just opened themselves up for a slander suit.
Interesting to say the least.
This is definately crazy. FDA saying there are ethics violations and HEB/Doctors saying this thing works in at least 25% of the CFS populace.
Only way this gets approval in Feb. is with an overwhelming Adcomm vote.
What is crazy is if they omitted numbers or records of adverse incidents went missing why was this not reported for ethics review? Why is this in ADCOMM?
Looking like a big soap opera. Waiting for the vote but not going good with the FDA folks.
LOL trading on technical analysis on a company right now being accused of ethics violations in their trial.
LOL That is rich. I am glad I got up early to look at the breafing docs and bailed.
Just off of what the FDA is presenting HEB will be hammered by the SEC, shareholders with a lawsuit. And lets not forget penalties or revocation of licenses for ethics violations. They have come right out and accused them of fudging the numbers. And covering up safety issues with the drug.
Well it is not looking good at all. They are basically acusing HEB of ethics violations and fraud in their safety statistics. I see securities class action lawsuits coming if everyone believes the FDA prsentation. None of this was disclosed properly by HEB in the studies and they are in fact being acused of hiding negative data.
Not good at all.
Yes it is very bad. Horrible tech support.
From what I can gather they are hammering HEB though. They do not like the statistics and are unimpressed with the reevaluation and are questioning their ethics.
More short sells on L2 coming. Might drop this into the .20's
Learn your lesson never try to catch a falling knife... And the bottom on this is around .33 according to the charts. If it breaks that all bets are off.
Pumper LOL. Ok
There is still real value with this company. Ampligen after reading the summary just is not going to get it done right now imo. I will revisit this at a lower pps and save some considerable cash in doing so. There are still good things here but why waste money when it is going south.
Going to watch from the sidelines now. The summary pretty much told me everything I need to know. If it goes positive I will chase. But from the summary it pretty much looks like no way in hell the FDA wants to approve this. IMO.
I have seen some negative summaries but this one is in the top 5.
Current Phase 3 HIV China
Phase 2b HIV US
Avina Flu Preclinical Japan, US and Canada
There has been other research out there by third parties too.
The Ampligen NDA with the FDA is only half the story. HEB has an ANDA in with Argentina for Alferon N in specific non reactive Hep C cases with a large statistical significance success. Also an NDA in Argentina for Ampligen in CFS/ME.
Usually they are posted around noon. Expect it to be negative... They are asking tough questions but many investors panic at the sight of these... Why I do not know.. Every company and drug gets similiar treatment.
This right now is cheap.
Two shots to go big in the next 12 months. Or could go huge if it gets both.
Ampligen NDA US for CFS/ME
Alferon N ANDA Argentina for Hepatitis C non-reactive to recombinant interferon.
With the financials looking positive I have changed from a flip to long.
http://www.prohealth.com/library/showarticle.cfm?libid=16037
Read this and you will see why people are trying to get shares on the cheap. And why I believe this will get accelerated approval with the condition they back this up with additional data 1 to 2 years from the meeting in Feb.
Have not read the article but being honest about your position says something.
On the other hand we have had multiple articles in the last two weeks with information missing or lied about. And we are not talking about information that is hard to cross reference. Kind of makes it look like some writers are trying to scare people out of positions by using false information to discredit HEB.
Why would they have to give false information if this was a bad drug?
Yes very much so. Reason why is to give the company room for expansion, R and D etc. That is if Dr. Carter and company decide to go it alone.
Multi Billion is right though. What is the real draw is the fact HEB is partnered to develop blood tests specifically for CFS and in that also test for subgroups that would respond to Ampligen.
Conservative works for me.
I base this off of my own calculations that factor the following:
Current Market Cap
Full dilution of AS
EPS
Market size for product
Estimate of final costs
Estimate of overhead
Current Market Cap of Comparisons
Current EPS of Comparisons
Comparisons AS
Current ratios of comparisons and this company
Total liabilities and revenue of comparisons and this company
As you can see a lot of homework.
What I do see happening is accelerated approval on conditions they confirm it in another study. What does this mean? They can sell the drug as an approved treatment but have to gather the further data requested and then full approval will come on confirmation.
Which means the company will start turning toward a positive cash flow in a hurry.
You have to give credit where credit is due. Dr. Carter has not run up huge amounts of cash burn on this company in comparison to others. Going for accelerated approval while they are currently trying to fill another trial is a smart business move. It will give them cash flow and allow this to be a covered treatment, thus filling their confirmatory trial with numbers.
If you actually do homework on this one you can find several things Adam Feuerstein has out right omitted or lied about.
Two for example:
"No patients want the drug" Although he is right about it has been available under compassionate use the costs are more than most could ever afford. Relocation, 24k per year for treatment etc. And that 24k is not all for the drug. That sure is alot to come out of pocket for.
His statement that they skewed the same study is also incorrect. What HEB did was take the last 6 months of treatment and look again at the numbers which show after several months there was real improvement.
There are others but hey I do not write for a living.
Adam does this all on his own. He will in the end get caught playing the game. He is after all the fall guy and messanger all in one.
People like Manuel Asensio made fortunes using people like Adam to do their bidding. I know several companies that he shorting went BK. Well why do companies go public? More often than not for funds. When you spread bad press they lose one primary method of raising capital, and in some instances other ways too.
This is exactly why Manuel Ascensio was sanctioned for his activities. Unfortunately he served no jail time.
Good information.
We all know who she is talking about. And if anyone wants they can see from this link he did no DD. He has been writing in this sector for years and his information is still wrong. Could it possibly be for personal reasons due to the fact that Dr. Carter did not put up with his personal attacks. I think so.
http://www.mayoclinic.com/health/compassionate-use/AN02061
Why he is still employed and continues to out right lie in articles is crazy. And they wonder why they ended up in litigation.
2-3 dollar pps if positive ADCOM
Once approved trading range of 5 - 10 in the next year.
Further development of the pipeline, the blood test for CFS etc. will push trading range 10-15 dollars.
Really all in all the companies financials and legal problems are ironed out. If Ampligen gets approval the manufacturing facility has already been brought up to standards etc. Debt to equity ratios look very good for a company with only one drug approved.
If ADCOM is positive you will see this turn from a day traders stock to an invest and hold stock.
And just in case Adam visits...
Here is a link to the Mayo clinic so Adam can bone up on and actually understand what the compassionate care program works. Obviously he has never taken the time to understand how it works.
http://www.mayoclinic.com/health/compassionate-use/AN02061
One thing he failed to mention is that although made available it will not be paid for. IE. Insurance and Government programs would not pay for the drug.
So who pays for it? The patient.
He kind of left that out.
Also do not let me forget. He is or has been sue by shareholders and comapanies a like for stock manipulation and defamation.
I would not even worry about Adam. Anyone trading on his rec. ends up broke.
At one point he said CFS was not a disease several years ago. Then he came back with this.
"CFS is a serious disease, but it's not life threatening. And Ampligen, if approved, is designed to be a chronic, long-term treatment -- a drug that patients will be given by intravenous infusion twice a week."
In a 2009 article.
You just have to remeber he is writing columns for a living cause he is not a good trader. He is and has been for most of his adult life a professional columnist that has a degree in political science with no expertise in the markets or biotech.
Agree.
Adam F. talking trash on HEB again.
Let me ask you Adam.. Why do you make a living as a columnist?
With your superior skills at deciphering the markets you should be filthy rich.
I am guessing the same reason as all the other experts with blogs, shows and columns. Most of their opinions turn out to be busts.
Thus understand what these people like Adam say and why. But never invest off of their recommendations.
And I forgot they would not accept the submission and do it during the holiday calender if the information was not worth reviewing.
Nobody wants to work anymore than they have too during the holidays.
I would say 70% or better. Here is my reasoning why:
HEB does show according to the numbers they are submitting a definate quality of life improvement.
The culture at the FDA seems to have changed views on drugs for diseases on CFS/ME. Maybe because of political or not. But this can not be denied.
There is no dedicated treatment as of right now. Just off label treatment of CFS/ME.
Several CFS/ME experts and patients have reported very good results and some amazing results with Ampligen. Just like any other treatment approved or not some patients will do well and others not.
I do understand where the analysts are bashing HEB. But it is important to understand not invest solely on analyst reports. If it was that easy those analysts and columnists would be retired not writing for a living. If I solely traded off of columnists and analysts predictions I would be broke. This is why I do not pay for such services. These people would not have to make a living doing that if their opinions are spot on. They would be the richest people in the world.
LOL...
Just stating the facts. The confidence in the run has been killed.
To bad could have been alot better but you win some and lose some do not get too upset.
This will go nowhere unless it gets a positive ADCOM. The Hedges got greedy and killed any confidence in the stock by hammering it day in and day out. Could have seen 1.20+ before ADCOM but now it won't even come close to .80
Oh well.
If they did not cover on the dips interday they are going to be crushed. Volume is starting to flow into this thing now.
LOL
Someone missed the boat.
What is preplexing is this stock is under attack by an organized group of short sellers.
Alot of covering on 12/10 as you can confirm by the numbers on finra.
Yesterday the shorts sold another 35% of all volume. Looks like until there is some market interest in the stock the organized short attack PR campaign will continue unabated.