Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I believe a company has 3 days to announce an approval before it will be posted by the FDA?
I don't know, but if that was an official PDUFA date then they would have until today to notify of the decision?
Thanks, you too :)
That's what I'm hoping. I don't think Sage would participate in the CC unless something's actually been accomplished.
Hopefully we will have news..
Seriously?
Do you guys know what time the meeting is tomorrow?
Sorry, I'm away this week and it's hard for me to look things up on my phone.
I think he only worked at StemCyte until Oct. 2008:
http://biz.yahoo.com/e/090617/heb8-k.html
Sorry I was too late to add this to my original post:
"The Centers for Disease Control and the Health and Human Services Department will receive $1.5 billion in additional fiscal year 2009 appropriations, as well as $5.8 billion for a contingency fund for expanding detection efforts, increasing federal drug stockpiles and developing and administering vaccines."
http://www.federaltimes.com/federal-times-blog/2009/06/11/congress-to-approve-77-billion-for-flu/
House Passes War-Spending Bill
"The bill includes $7.65 billion to ensure the federal government is sufficiently prepared to combat a possible pandemic of the H1N1 flu virus. The World Health Organization increased its warning on the flu outbreak last week to its highest level, indicating it now believes a pandemic is under way."
http://online.wsj.com/article/SB124519228779520783.html
Still needs to be passed by the Senate and signed by Obama (who I believe was advocating for it)..and obviously we have no idea if it would include anything for HEB...
Also, apparently $5.8 billion is for contingency emergency funds:
http://asia.news.yahoo.com/ap/20090617/twl-us-congress-war-funds-glance-ef375f8.html
Thanks, I wasn't counting that as salary since it was primarily option awards..
Where are you finding $3 million? I see $664,624 for 2008 and $637,496 for 2007..at least according to their 10k...
http://yahoo.brand.edgar-online.com/displayfilinginfo.aspx?FilingID=6481064-198685-277184&type=sect&dcn=0000946644-09-000003
Do you all think that short covering will significantly increase the pps following approval (assuming Ampligen is approved) assuming that there are still about 7 million shares shorted when the announcement is made? (http://shortsqueeze.com/?symbol=HEB)
Or is it more likely that people will wait for the price to settle before covering?
No, I just checked; the website is still down..
Apparently the interview will be available tonight at 8 p.m.:
http://www.webwire.com/ViewPressRel.asp?aId=97078
I think today's PR is an indication that Ampligen will be used as an adjuvant by the Japanese in the near future.
"There are only four makers in Japan that can produce the vaccine, mostly research organizations and not major pharmaceutical companies". http://www.reuters.com/article/internal_ReutersNewsRoom_ExclusivesAndWins_MOLT/idUSTRE5540Q620090605
So it appears that Biken will likely play a large role in vaccine production.
Also, I don't think a partnership with Biken would exclude other institutions from also using Ampligen as an adjuvant.
And according to Carter in a recent interview:
"The highest level of the Japanese government and public medical community is now focused exclusively on our product. They stopped working on all other adjuvants (boosters) and are only working with this one because they’ve found that it enhances the vaccines by 100 fold.” http://jinandjuice2009.wordpress.com/2009/06/06/heb-strong-buy/
Also, this PR doesn't contain anything about FDA approval because there is nothing apparently to report as of today.
This is obviously just my interpretation...
And it seems that Biken already has good production capability:
BIKEN has been developing and producing vaccines since 1952 and produces
approximately 4% of the world's vaccine supplies, including vaccines that are
FDA-licensed for use in the United States...(as of 2007)
http://www.reuters.com/article/pressRelease/idUS163409+13-Dec-2007+PNW20071213
Great news, thanks :)
I would think (although I'm guessing) that if the FDA were planning to take considerably longer than 2 weeks to inform HEB of their decision, then they would have notified them of another delay? I would think any announcement within a 2 week 6 day timeframe could still be considered reasonable...
Also, I would assume that since Ampligen will be the first drug approved specifically to treat CFS (rather than just the symptoms) then there's more details involved than for most other drugs (labeling issues and what not) which caused the delay...Anyway, I can't imagine what reason the FDA would have to delay the decision if there was going to be a denial, particular when there's an entire group of people suffering from CFS who already feel they've been marginalized by the health-care system and are awaiting a decision...
Again I'm just speculating on all of this..
WHO getting close to declaring H1N1 pandemic:
http://www.reuters.com/article/healthNews/idUSTRE5583US20090609
I am...just watching for news...
Good luck everyone.
Back up to $3.20. It only dropped to $2.28 on one 163 share transaction.
Good find, thanks.
I agree, that was ridiculous...
without factoring in a contract with Japan..
(I read on google they're planning to put together a revised estimate taking that into account.)
Japan to produce new flu vaccine this year:
http://www.reuters.com/article/internal_ReutersNewsRoom_ExclusivesAndWins_MOLT/idUSTRE5540Q620090605
Right and Dr. Podell seems sort of sketchy. Anyway, he's a holistic doctor with no connection to HEB:
http://www.drpodell.org/
I copied this from another board:
Email from HEB...
Dr. Hideki Hasegawa, Chief of the Laboratory of Infectious Disease Pathology, Department of Pathology, of the National Institute of Infectious Diseases, Tokyo, Japan, published a peer reviewed publication titled "Development of mucosal adjuvants for intranasal vaccine for H5N1 influenza viruses" was published in Therapeutics and Clinical Risk Management 2009:5 125-132.
The scientists identify Hemispherx Biopharma's drug technology as the "most promising mucosal adjuvant for influenza."
PDF:
www.dovepress.com/getfile.php?fileID=4595
Apparently HEB posted new job openings today (could be unrelated, but I thought it was interesting):
http://www.hemispherx.net/content/careers/
But you got the number right :)
I just saw a buy order executed for 284k shares..
I feel the same way. Good luck everyone :)
It's posted in the news feed on google finance. I agree, though, it has to be something else..
Maybe a short covering after that article was put out? It's hard to believe that that could have caused a 40% rise though...
2.39 :)
Actually about 4.8 million in the last 20..?
About 3.2 million within the last 15 min.
About 3.2 million within the last 15 min.
Thanks so much pygdoogg. I appreciate your response.
I have a question. In the article Feuerstein says:
The abstract clearly states that the 12.9% improvement in exercise performance between Ampligen and placebo patients was not statistically significant, with a p value of 0.052. Any result with a p value of greater than 0.05 is deemed not statistically significant.
But in the abstract that he cites it says:
In the recently completed Phase 3 trial, patients receiving Ampligen for 40 weeks improved exercise treadmill performance 14.8% compared to the placebo group (p = 0.025) and 12.9% by intent to treat analysis (p = 0.052), and this improvement represents twice the minimum considered medically significant (6.5%).
Unless I'm reading it wrong, they're saying it is statistically significant?
Also, I read in another article:
Results from the Phase III clinical trial indicate that Ampligen works. The difference in improvement in exercise treadmill duration in the Ampligen cohort compared to placebo was 13.6%, which is over twice the minimum considered medically significant (6.5%) (p=0.022).
http://smallcaps.us/blog/?p=21
I guess I'm wondering if anyone else has any other information on the p value for the study?