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lol, I was about to post the same thing..
I think dvax did not tank after docs release because everyone knew about safety concerns and there were no surprises. With heb its the efficacy. From what I have learned side affects can be minimized with correct dosage.
Me too. I have more than I planned on buying. That being said I will buy more if this slips down more after doc release. I do not expect that though because I think weak hands have sold. I expext a small bump if there are no surprises (ie major concerns other than efficacy)
I agree that it will most likely be a positive vote. The question is by what margin? If there are only two negative votes and 1 abstains for example the price will sky rocket. I guess we shall see.
No run up but this is coiled up like a spring. A 20 % gain tomorrow will only bring more attention to it leading up to adcom.
Can not believe how much this dropped in last month. A eraged down but cant keep to much capital locked up in this. I do see this as a great stock to hold for 6 months thogh.
I think the hedgies are expecting favorable briefing docs and are tryng to get more shares.
Margin of approval will have a big influence on price as well. For example if all but two recommend approval then we will see a huge increase in pps.
Once a couple of other "plays" run their course over the next two weeks this will move.
I am hoping Briefing Docs will be imformative. (And without suprises) I do not think safety will be a concern. Efficacy will be the major issue. Below is info on CRL from 2009. Hope all other issues have been resolved.
Hemispherx Biopharma Receives Complete Response Letter From FDA on Ampligen(R) New Drug Application for Chronic Fatigue Syndrome
PHILADELPHIA, Dec. 1, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company" or "Hemispherx"), announced that it received a Complete Response Letter from the U.S. Food and Drug Administration ("FDA") which describes specific additional recommendations related to the Ampligen(R) NDA. In accordance with its 2008 "Complete Response" procedure, the FDA reviewers determined that they cannot approve the application in its present form and provided specific recommendations to address the outstanding issues. Hemispherx is carefully reviewing the Complete Response letter and will seek an expedited meeting with the FDA to discuss its recommendations. Management is pleased to have received specific advice on the remaining issues and is looking forward to making a thorough but expedited response its top priority, and plans to take all appropriate steps to seek approval and commercialization of Ampligen(R).
Most notably, the FDA stated that the two primary clinical studies submitted with the NDA did not provide credible evidence of efficacy of Ampligen(R) and recommends at least one additional clinical study which shows a convincing effect and confirms safety in the target population. The FDA indicated that the additional study should be of sufficient size and sufficient duration (6 months) and include appropriate monitoring to rule out the generation of autoimmune disease. In addition, patients in the study should be on more than one dose regimen, including at least 300 patients on dose regimens intended for marketing. Finally, the additional study must incorporate both a well-controlled QT interval study and pharmacokinetic evaluations.
Other items required by the FDA include certain aspects of Non-Clinical safety assessment, and Product Quality. In the Non-Clinical area, the FDA is recommending that the Company complete rodent carcinogenicity studies in two species. As part of the NDA submission, the Company had requested that these studies be waived, but the waiver has not been granted. Certain additional non-clinical studies and additional data to support non-clinical studies already submitted with the NDA are also recommended by the FDA. Prior to the receipt of the Complete Response letter, the Company had already begun many of these additional studies and the collection of the requested additional data.
Under the Product Quality section of the Complete Response letter, the FDA recommends that the Company submit additional data and complete various analytical procedures. The collection of these data and the completion of these procedures is already part of the Company's ongoing Quality Control, Quality Assurance program for Ampligen(R) manufacturing under cGMP (current Good Manufacturing Practice Guidelines) and the manufacturing enhancement program recently undertaken by the Company and announced in a news release on September 16, 2009.
Finally, the FDA commented on Ampligen(R) manufacturing noting the need to resolve outstanding inspection issues at the facilities producing Ampligen(R). These include the Company facility located in New Brunswick, NJ and one of the Company's third party manufacturing facilities (Hollister-Stier Laboratories). The Company has been working to resolve these issues.
At this time the Company's management has not determined the impact of the additional recommendations set forth in the Complete Response letter on the timelines and overall cost of the Ampligen(R) program, but the Company's management has made response to the issues and satisfaction of any additional requirements a top priority. The Company will seek to meet with the FDA to clarify any issues identified in the Complete Response letter and to work with the FDA to identify the most expeditious path to satisfaction of the requirements for approval of the Ampligen(R) NDA.
LINK: http://finance.yahoo.com/news/Hemispherx-Biopharma-Receives-pz-1501240985.html?x=0&.v=1
Briefing docs should have impact on price pre adcom.
My hope is that they are using money from ATM to make sure there manufacturing facilities are up to snuff. At least this would be a reason to sell ATM at this level. I believe the last CRL had some issues with manufacturing.
$heff invested bought in last Friday. Should help raise pps
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=82290395
Im gonna set some buys below a dollar also. Have to believe there has to be some stop losses there.
If I had more powder I would be back in today. Still have some time but the lowest we see b4 PDUFA date.
Expecting late dec this will start to roll
this has been a great trading stock for those people who can watch and get in and out. I ve managed to do it a few times but since I have a full and part x job I was worried about getting out and missing the proverbial boat.
This will break a wall on Friday. ? is which wall. Would love to grab some low 70's and then finally bust through .83
another bio stock pulled back their offering today "due to market conditions" so who knows
Ecte possible bounce? New offering AH
I would not be surprised to see a "Street" or SA article out tomorrow morning. Going to try to take advantage of the volatility tomorrow.
I was about 2 type same thin Kei. I bought 2000 more at 1.65 ...... hoping this bounces with a conference call to mid 2's???? Hope..
trading like some one wanting to push the price down to get cheap shares. I bought some more. Think it bounces back up.... We will see.
Buying at this level.
Buying every x it drops.
NAVB pdufa date 4-30-13
Think they may need to raise some cash.
DVAX 4.35 premarket at 8:54 Glad I averaged down on this.
Its a panel date only with a recommendation by independent drs statiticians , ect. One of the reasons this has dropped was worry if crl due to no panel date being announced.
Florida panhandle will report later and should be pro romney
Not sure why he did not say a lot of things. He just took his foot off the gas pedal for some reason.
It all comes down ti ohio
although he was on a liberal channel I kind of miss Russert for his outlook on different districts within a state on election night. Ohio in particular.
APPY FDA accepts nda for apf530 PDUFA date 3-27-13
.61
http://www.appharma.com/PDFs/10-16-12-APF530-NDA-Acceptance.pdf
Lol. Plus I so think I will make a higher return of of my .65's than elsewhere within a few days.
Norm
I'm down big but I think in the end I wil be glad I had the opportunity to avg down. Just could of used the capital else where.
Heb. I think that since they already sold @ 25% of offering, they will not sell more than 25% more of the 40000 before adcom. I think they are confident of a positive vote and anticipate the stock to be much higher than it is now end of December. They can raise up to 75 mil. That means that that the remaining shares thwy have to sell must avg 2.50+. I actually see positive reaction Monday.
Over 25% of offering already sold. I think that it is safe to assume that they have sold more since the 1st of October also.
THE OFFERING
Offering Price, Shares, and Proceeds: Variable at-the-market pricing, with aggregate gross proceeds of up to $75.0 million. Up to 40,000,000 shares of common stock have been approved and allocated to the offering. As of October 1, 2012, 10,919,700 of these shares have been sold.
offering that may be made from time to time through our agent, Maxim
Manner of Offering: “At-the-market” .
**I am hoping that there next "time to time" selling will be after panel lol**