Releasing the Financial and Development Report on a Monday (March 9th) implies that good news is coming, as opposed to releasing the Report towards the end of the week? Do you think so?
January 12, 2015: Hemispherx Biopharma, Inc. (NYSE MKT: HEB) (the “Company” or “Hemispherx”), reported today that it has conducted new in vitro studies of natural killer (NK) cells obtained from CFS patients in conjunction with a comprehensive review of the medical literature to determine the relative incidence of NK cell functional deficiencies in CFS disease. This review indicates that low NK cell cytotoxicity (NKCC) has been consistently reported in CFS patients compared to normal controls. In the new laboratory studies, Ampligen® (rintatolimod), an experimental therapeutic, was found to increase in vitro NK activity utilizing cells from CFS patient donors.
Ampligen® (rintatolimod), an experimental therapeutic, increased mean NK cell activity in vitro over 100% in the fifteen (15) CFS patients who donated NK cells. The mean age of the subject population was 48 years and two-thirds of the subjects were female. The observed NKCC increase was achieved with concentrations of Ampligen® achievable with a standard clinical treatment regimen of 400 mg given twice weekly. More than 100,000 doses have been given clinically, principally to CFS patients.
An FDA Advisory Committee, convened in December 2012, when asked “Is the safety profile of Ampligen® adequate for approval for the treatment of CFS?”, the “Yes” vote was 8, and the “No” vote was 5. When asked has the application “provided sufficient efficacy and safety data to support marketing of Ampligen® for the treatment of chronic fatigue syndrome?”, the “Yes” vote was 5 and the “No” vote was 8. Thereafter, the Agency declined to approve the marketing application. Subsequently, the Company has been in dialogue with the Agency as well as selected regulatory authorities worldwide regarding potential paths forward to advance the experimental product for potential treatment of severe CFS.
TTNP is earning good amount of revenue from its products. So, this stock will rise on its own, in addition to the upcoming clinical results and potential approval of the new drugs.
David Dodd, Chairman, CEO at Aeterna Zentaris stated, “Patient recruitment for our ZoptEC Phase 3 trial in endometrial cancer, our lead oncology program, is in line with our projected timelines to secure a first interim analysis in the first half of 2015 by an independent Data Safety Monitoring Board. Today, there is no FDA approved therapy for treating women suffering from advanced, recurrent or metastatic endometrial cancer. Our hope is that our novel product will be successful in this trial and subsequently, become a core tool in improving the lives of women with this type of cancer. Also, we are very pleased to be working with the Hollings Cancer Center at the Medical University of South Carolina for this trial, and look forward to other future collaborations with this most prestigious institution as part of our plan to establish activities in the Charleston area, one of the most thriving and exciting business communities in the United States.”
GTHP said they will announce some information about international sales when they release their Financial and Revenue Report in March. It could be sales that already took place or expected sales in the near future. Let's hope they generated some profit towards the end of last year. Good company.
I hope DNDN receives a buyout offer of $4.8 BIllion, which is about $26 per share. I bought at $52 in 2010; and even with a buyout of $26 per share, I'm still at a loss. But I hope the shareholders get something really good from the auction.
LuViva is approved in Canada and has received CE Mark in Europe. The FDA should consider these facts and approve LuViva in USA.
The LuViva® Advanced Cervical Scan was chosen as best designed new medical device of 2014 at the 17th Annual Medical Device Excellence Awards (MDEA) ceremony held Wednesday, June 11, 2014, in conjunction with the MD&M East event at the Jacob K. Javits Convention Center in New York. LuViva, a newly introduced product for the early detection of disease that leads to cervical cancer, is manufactured and sold by Guided Therapeutics, Inc. (OTCBB:GTHP) (OTCQB:GTHP).
LuViva was chosen as the Gold Medal Winner in the Hospital Devices and Therapeutic Products’ category by a panel of independent experts due to excellence in product innovation, design and engineering achievement, end-user benefit, and cost-effectiveness in manufacturing and healthcare delivery.
“Receiving this award is a validation of the design and engineering effort that went into creating LuViva,” said Gene Cartwright Chief Executive Officer of Guided Therapeutics. “Not only is LuViva very user-friendly to operate, but it communicates the strength of its underlying technology to the patient and healthcare professional. We want to thank our design team at Big Bang and our key suppliers, Seaway Plastics, Gupta Permold and Herman Miller for their ongoing support.”