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Almost forgot, if you are a little guy/gal and got in under 3 bucks then you can sleep better at night because those manipulators should not affect your overall outcome :)
GO CTIX!!!
Don't get me started. Let's just say GO CTIX!
You can't blame Obama for insurance companies trying to make a profit. RX s have always been scrutinized and this is nothing new.
D is contraindicated for those with renal failure/renal insufficiency or unbalanced electrolytes. This gives b an automatic market. Add in lack of resistance, the fact it's cheaper to produce and store and that you don't need to be hooked up to an IV and POW!!! B will be welcomed with open arms by physicians around the globe.
So those yahoos think Harvard, MD Anderson and UofB make plans and spend money based on "hot air" and less than impressive data?
GO CTIX!!!
I think it's hard to hit $10 bucks without an inked deal. BUT I don't see why we couldn't get in the neighborhood once B is unblinded and we hit the major news outlets. It might even break past $10 with good media coverage and then pullback until a deal is made.
My two cents of course. GO CTIX!!!
Thanks!!! Sorry about mom.
I think I'm just as excited about it as Dr. Menon now!
Dr. Menon seemed very excited about developing a cure for Klebsiella pneumoniae.
Does anyone have any idea as to the market size for that???
GO CTIX!!!
You must be Grorgi kin.
Quiet period for a deal :) .... I hope!
2 means you are over qualified! Lol!
Go CTIX!
Along the same line of thinking as your post, Malaria and Tuberculosis hurt 3rd world countries disproportionately but have always had the potential to to affect the globe. Fortunately, CTIX is developing an arsenal that should change the world for the better.
***GO CTIX!!!
Second, I hold a Master of Public Health (MPH) and am CPH. You sound like a fellow MPH. Is this your background???
I'm counting the days! Quiet periods are our friends :)
I had a dream a few months back where the DoD was stockpiling B in case of Anthrax attack.
They are looking back at the 5 year chart in search of gaps!
I hope we are in a "quiet period". Every day that passes adds fuel to the rocket.
Since we are in October I am only expecting B results before the end of the year. The P study may start this year but results will not be available till 2015 and K is a freight train... Just doesn't stop that easy. K safety isn't really in question but the full analysis of the other study goals will not be available till mid 2015 or later. ***We could however get results from MD Anderson and find out what they have been up to any day now.
I'm not. I want one 30 day out from the last PR. That's what will bring all eyes on CTIX and PPS to double digits :)
I say no one misses you now.
CTIX has finally gained partial validation for the poly heist and as new eyes appear and do their own DD it is becoming overwhelmingly apparent that CTIX is a sleeping giant.
My Georgie bless you and GO CTIX!!!
Well said! Lmao!
Your psy-ops have not been effective. Time to give it up and go elsewhere.
GO CTIX!!!
In the times of chimpanzees I was a monkey... But now I'm a CTIX long!
Thank you. Short and sweet and most importantly, to the point. We need to focus in science and business transactions and NOT on self declared doctors of x, y, and z or Georgie.
You do not, nor will you ever represent Dr. Frei. Don't twist his words or distort his message by adding your spin.
Da Bears! And GO CTIX!!!
Best use of 10 bucks I've ever seen! Good on you!
Someone took your advice and purchased 4 shares at 2.55 lol!
Market equilibrium on I hub at least lol!
From my webcast notes:
"Submitted request to meet with FDA for a pase II/III plan"
DoD. We are everywhere in the world and we will pay top dollar. 2 million deaths per year is no joke.
I'm sharing my notes from the R&R webcast in hopes that others will too and we increase our knowledge base.
GO CTIX!!!
1. Kevetrin
a. Starting 350mg/m² week of September 8th; CA-125 had 7 dosing cycles; Grade 2 Erythemia easily treated with pre-medication; no grade 2 SAEs in 8th cohort should result in faster progression; 3 September, University of Bologna study received ethics approval
2. Brillacidin
a. Cure rate at 7 days higher than Daptomyacin; 75% of study Brillacidin; B-OM IND submitted for phase II; Toxicology report received last month (August sometime);Awaiting to meet with FDA to develop Diabetic Foot Pathway
3. CTIX 1502
a. Single Topical Application against Candida; “Superior to other anti-fungals”; Little cytotoxicity; Unmet Medical Need
4. Prurisol
a. “Great unmet medical need”; Submitted request to meet with FDA for a pase II/III plan
5. Delparantag
a. Treatment for COPD with dosing modification; “Mouthwatering”
Most of the incentives are aimed at developing these new drugs/vaccines and stockpiling is a secondary end point. No one has deeper pockets than the FEDS and they are doing their job by promoting the advancement of new technology by reducing the pharmas risk in the process through their funding as they proceed through FDA approval process.
Love your comment.
"and if its a matter of national security or public safety I want them developing and stockpiling drugs as they see fit..thats why we elect them..we are all shareholders when it comes to the national defense and the general welfare"
Blzzy, very good point. We forget that the biggest payer in healthcare is the federal Gov and our strategic plan should include an element addressing that fact.
Frrol, I totally understand your concern. I continue to dig and it seems that the incentives that are available are meant to encourage development of drugs such as B.
***I really think Leo is telling big Pharma "we don't need you and your stink bids... We have options"
Check this out: http://www.medicalcountermeasures.gov/barda/cbrn/broad-spectrum-antimicrobials.aspx
The U.S. Department of Health and Human Services has a requirement to develop broad spectrum antimicrobials for the following biological threat agents: Bacillus anthracis, Yersinia pestis, Francisella tularensis, Burkholderia mallei, Burkholderia pseudomallei, Rickettsia prowazekii, orthopoxviruses, filovirus, and Arenavirus (Junin virus). The Biomedical Advanced Research and Development Authority (BARDA) is expanding its role in the development of these medical countermeasures (MCMs) by concurrently providing funding for the development of novel therapies that will address the public health issue of naturally occurring antibiotic/antiviral resistance.
Broad Spectrum Antimicrobials Medical Countermeasure Efforts
The 2010 PHEMCE Review stated that "Our Nation must have a nimble, flexible capacity to produce MCMs rapidly, in the face of any attack or threat, known or unknown, including a novel, previously unrecognized, naturally occurring emerging infectious disease."
In order to help achieve this vision, BARDA's Broad Spectrum Antimicrobials (BSA) Program was established in January 2010 and is focused on developing novel antibacterial and antiviral drugs for the treatment or prevention of disease caused by currently defined and future biological threats. BARDA also recognizes that new antimicrobials are needed immediately to address the increasingly prevalent public health threat of antibiotic resistance, as well as the likelihood that antimicrobial resistance will complicate standard treatment of a wide array of infections. BARDA hopes to revitalize the antimicrobial pipeline by providing incentives for pharma and biotech companies to engage (or reengage) in antimicrobial development.
The BSA Program's non-dilutive funding strategy provides our partners with capital to support product development and supplement existing equity. BARDA is establishing public-private partnerships with industry partners for the development of novel antimicrobials and anticipates a long term commitment to this market. Through these partnerships, BARDA will support concurrent development of candidate products for biodefense and commercial indications based on strategic and funding priorities outlined in our BAA.
This strategy helps ensure that novel antimicrobials will progress through the development pipeline to approval for a clinically prevalent indication. It increases the likelihood that novel antimicrobials will be added to the arsenal of possible treatments available to counter resistant infections. Approval of a candidate for a commercial indication also helps establish a human safety database and a warm base manufacturing capability for the drug should it be needed in a public health or biothreat emergency scenario.
By engaging with BARDA in a contract our industry partners are able to receive funding and technical consulting support from BARDA for preclinical studies, clinical studies (Phase 1-3), manufacturing, and regulatory activities.
I respectfully disagree. It's intended to ensure National Security and since biological warfare is a real possibility we should as a nation invest in defense of it.
Call me crazy, I'm certain there was a reason to call out the executive order and even include a link to it in the PR.
My thinking is that he may be telling big Pharma "Step up the bidding or we will go it alone with the help of the Feds". OR he may actually be considering taking the B platform all the way with FEd help. In any case, the wording and bringing attention to the executive order is very telling.
This is only one way they incentivize development of antibiotics but there are other programs that will help with the platform ;)
Take for example the aid that they are providing to Glaxsmith:
Authors: Joe Larsen, Acting Deputy Director, Division of CBRN Countermeasures, Biomedical Advanced Research and Development Authority (BARDA), Office of Assistant Secretary for Preparedness and Response (ASPR) and Tyler Merkeley, M.S. MBA, Broad Spectrum Antimicrobials (BSA) Program, Division of CBRN Countermeasures, Biomedical Advanced Research and Development Authority, Office of Assistant Secretary for Preparedness and Response
At BARDA, we want to revitalize the antibiotic pipeline. To do it, we’re pursuing an innovative business model and providing incentives for pharmaceutical and biotechnology companies to invest in antibiotic development.
BARDA has successfully established public-private partnerships with industry partners for the development of novel antibiotics and anticipates a long term commitment to this market.
BARDA has seen the companies we partner with raise additional funding in private markets, become more attractive assets for acquisition by larger pharmaceutical companies, enter into co-development agreements, and/or move forward with Initial Public Offerings (IPO). This additional funding can provide critical capital to support expensive Phase III clinical studies. While there are factors that impact each business decision our partners have made, it is clear that those that have partnered with BARDA have continued to accomplish important technical and business milestones. Securing technical guidance and financial resources through a BARDA partnership reduces the risk of drug development, freeing up additional resources to help companies grow and diversify.
We strive to be a collaborator and, as a result of our direct involvement, to mitigate regulatory uncertainty in developing antibiotics and other drugs, vaccines, and diagnostics.
In May 2013, BARDA entered into a unique strategic alliance with GlaxoSmithKline to launch a Portfolio Partnership. This Portfolio Partnership is a five-year, $200 million agreement formed under the Other Transactional Authority (OTA) granted to HHS by the Pandemic and All Hazards Preparedness Act of 2006. Partnerships formed using OTA aren’t traditional government contracts and allow for more flexible partnering arrangements.
In this case, instead of focusing the partnership on a single antibiotic candidate, this partnership supports an entire portfolio of candidate antibiotic therapies. The benefit of basing the partnership on a portfolio of candidates is that the partnership doesn’t end if a particular product fails in clinical trials. BARDA’s agreement with GSK possesses three central tenets: 1) flexibility in technical scope, 2) cost sharing, and 3) joint strategic oversight. This type of flexible, long-term partnership sends a strong signal of commitment to industry.
Currently under the Broad Spectrum Antimicrobial programs, our partners receive reimbursement for drug development activities in real time. This approach contrasts with that of models such as advanced market commitments, where reimbursement is provided only after the purchase of product, and milestone or prize payments, where awards are provided upon advancing a candidate antibiotic to predefined endpoints.
The near real-time direct reimbursement for drug development activities is a preferred structure for products in advanced development prior to approval. The “non-dilutive” funding provided by BARDA to support development activities does not need to be repaid and does not dilute shareholder’s equity. Further, the funding can favorably impact the net present value calculation of our partners when considering whether to undertake antibiotic development projects by reducing their upfront costs.
The rapid growth of the Broad Spectrum Antimicrobial program – from one partnership in August 2010 to six partnerships today, with three progressing in Phase III clinical development – speaks to the success of BARDA’s model.
http://www.phe.gov/ASPRBlog/Lists/Posts/Post.aspx?ID=98
BARDA!
I cracked the code! When Leo called out the President he was thinking BARDA! One of the features if BARDA allows the Feds to totally buy out a Patent or partially buy etc PLUS prizes and incentives to develop the much needed antibiotic.
"One option would be complete delinkage. In this case, a drug developer might receive from the Federal Government a one-time lump sum payment that serves as a patent buyout and reward for bringing a new antibiotic to market. The Federal Government could contract with the drug company to produce antibiotic as needed, and limit clinical use to specific circumstances and certain pre-defined conditions. Under complete delinkage, buyouts in the range of $1 billion might be required."
http://m.whitehouse.gov/sites/default/files/microsites/ostp/PCAST/pcast_carb_report_sept2014.pdf
B's potential market is HUGE and difficult to assess. Antibiotics are extensively used not only to treat sick animals, but also to prevent infection and promote animal growth. All of these uses foster the evolution of antibiotic-resistant microbes, which can spread to humans so using B in agriculture is another market we've yet to discuss and deserving of a closer look.
GO CTIX!
This PR will bring a fresh new set of eyes on to CTIX :) It was genius because it should show up in some searches that are performed by those in the Public Health and Policy circles. Second to that he is essentially informing us to fasten our seat belts and prepare for lift off.
Polytheist will be historic!
GO CTIX!