If it was easy, why didn't they get it right and get the FDA approval? FWIW, the FDA doesn't look kindly on pharma companies that don't have a VP Regulatory Affairs responsible for NDA / CMC submissions, and Adamis never had one. Who is responsible for this critical function with the proper credentials? Nobody that I see on their web site or SEC filings
thanks, but I don't know the difference between proven speculation vs. unproven. Very confusing. Can't it be as simple as yes, vcsy is involved, or no, they aren't involved?
This sounds really exciting! goldribbon just needs to post the part of the article that confirms vcsy's direct
involvement and we'll be good to go
Can you please post the part that specifically states how this is related to vcsy? You must have simply forgot to copy and paste that part of the article. Honest mistake, right?
noonan, what makes you think end of March? I don't care if it takes another 6-12 months to get the beta right with the proper funding ( if they need it), etc to launch this platform and application
Noonan, isn't this similar to IBM's Softlayer? Would there be a synergy? Would IBM have an interest in Ploinks?
Yo neo, got a WAG for you. Would the apple watch use the tiny web server? Being tiny and all
From 2014 10K filed March 2nd. Looks like there's a need for another player in this market...
Our specialty pharmaceutical business is conducted through Mylan Specialty , which competes primarily in the respiratory and severe allergy markets. Mylan Specialty ’s portfolio consists primarily of branded specialty injectable and nebulized products. A significant portion of Mylan Specialty ’s revenues are derived through the sale of the EpiPen® Auto-Injector . During 2014, the EpiPen® Auto-Injector became the first Mylan product to reach $1 billion in annual net sales.
The EpiPen® Auto-Injector , which is used in the treatment of severe allergic reactions, is an epinephrine auto-injector that has been sold in the U.S. and internationally since the mid-1980s. Mylan Specialty has worldwide rights to the epinephrine auto-injector, which is supplied to Mylan Specialty by a wholly owned subsidiary of Pfizer Inc. Anaphylaxis is a severe allergic reaction that is rapid in onset and may cause death, either through swelling that shuts off airways or through significant drop in blood pressure. In December 2010, the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health, introduced the “Guidelines for the Diagnosis and Management of Food Allergy in the United States.” These guidelines state that epinephrine is the first line treatment for anaphylaxis. The EpiPen® Auto-Injector is the number one dispensed epinephrine auto-injector. The strength of the EpiPen® brand name, quality and ease of use of the product and the promotional strength of the Mylan Specialty U.S. sales force have enabled us to maintain our leadership position within this therapeutic category.
Big pharma should be sniffing around for a licensing deal for apc 5000. Developed by 3M and better safety profile than advair? Are you kidding me?
APC-5000 utilizes the patented Taper DPI inhaler device which, in this case, has been developed to eliminate the need for complex powder treatments and additive substances such as lactose, i.e. there is no need for excipients. It was also developed to deliver a higher percentage of fine particles to the airways with better delivery efficiency, and by doing so, decrease the drug deposition in the throat and mouth. Because of this increased efficiency, less amount of drug is loaded into the device thereby reducing the amount of drug given to the patient while still maintaining the same theoretical therapeutic dose. The study results confirm that systemic exposure to the drugs FP and SX is reduced after treatment with APC-5000, as compared to Advair(R) Diskus(R), thereby potentially increasing the overall safety of the product.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, "Based on the study conclusions and the extent of PK similarities between APC-5000 and Advair(R), we predict that our product (APC-5000), while using less drug, will still be as efficacious as Advair(R) for the treatment of asthma and chronic obstructive pulmonary disease (COPD). This hypothesis will be tested in a Phase III study comparing the efficacy of APC-5000 and Advair(R) for non-inferiority."
Adamis Pharmaceuticals Announces Positive Pharmacokinetic Study Results For Its Dry Powder Inhaler Product
SAN DIEGO, March 3, 2015 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (ADMP) ("Company") today announced the results of its pharmacokinetic (PK) study for its dry powder inhaler product, APC-5000. The study was a Phase I PK study comparing the bioavailability of Adamis' APC-5000 Dry Powder Inhaler (DPI) to GlaxoSmithKline's Advair(R) Diskus(R) DPI.
This PK study was designed as an open-label, randomized, single-dose, 4 period (2 sequence, 2 treatment, fully replicated) crossover relative bioavailability study comparing APC-5000 (Fluticasone Propionate (FP) 186 ug and Salmeterol Xinafoate (SX) 44.7 ug; 3 inhalations; total dose 558/134.1 μg FP/SX) and Advair(R) Diskus(R) 250/50 ug (3 inhalations; total dose 750/150 μg FP/SX). Sixteen healthy male and female subjects who met the study inclusion criteria were enrolled into the study. The study involved a screening period and four treatment periods separated by four days. After completion of screening procedures, subjects were randomized to receive two doses of each Test and Reference product in four treatment periods. All sixteen subjects completed the study.
APC-5000 utilizes the patented Taper DPI inhaler device which, in this case, has been developed to eliminate the need for complex powder treatments and additive substances such as lactose, i.e. there is no need for excipients. It was also developed to deliver a higher percentage of fine particles to the airways with better delivery efficiency, and by doing so, decrease the drug deposition in the throat and mouth. Because of this increased efficiency, less amount of drug is loaded into the device thereby reducing the amount of drug given to the patient while still maintaining the same theoretical therapeutic dose. The study results confirm that systemic exposur
WHY....do you assume others here don't know what happened at the meeting? You really think you are protecting inside information or something? NOT! Only about 25 people in total were there, correct?
Now that the increase in authorized shares was approved by shareholders, they will have the ability to raise capital if they need it to launch these new products. Amazing they were able to develop this platform and social network on a shoestring anyway. I know, dilution ain't no good, but it's better than having no options to raise capital
plugyourmouthshut, you really live in HI? I've been to Waikoloa a few times. Ever been?
Facebook bought whatsapp for 19 billion, an app with no revenues. Never underestimate the idiocy in silicon valley
SAN DIEGO, Feb. 24, 2015 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (ADMP) ("Company") today announced the results of its pharmacokinetic (PK) study for its beclomethasone dipropionate HFA product, APC-1000. The study was a Phase I open label, randomized, single-dose, four-way crossover PK study comparing Adamis' APC-1000 (Beclomethasone Dipropionate HFA, ["BDP"] 80 mcg Inhalation Aerosol) to Teva Respiratory, LLC's Qvar(R) (Beclomethasone Dipropionate HFA, 80 mcg Inhalation Aerosol).
Twenty-two healthy male and female subjects who met the study inclusion criteria were enrolled. The study involved a screening period before randomization and four treatment periods each separated by a minimum of three days. Both Inhalation Aerosols were administered to each subject for a total dose of 320 mcg BDP (4 inhalations). Twenty-one subjects completed the study. One subject was withdrawn due to non-compliance.
The purpose of this PK study was to compare the bioavailability of APC-1000 to Qvar(R). The results show the extent of absorption of APC-1000 to be equivalent to Qvar(R).
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, "Based on the study conclusions and the extent of PK similarities between APC-1000 and Qvar(R), we predict that our drug (APC-1000) will be as safe and efficacious as Qvar(R). We expect that this will be confirmed in an upcoming Phase III study initiated this year in which we will compare APC-1000 and Qvar(R) for non-inferiority."