at one point I thought this had to be put into a small stockpile.. ~40,0000 doses. It appears now that thinking was in error.. as were two govts. and dozens and an international drug co.. Shionogi.. HHS has $200M in this program at this point.. and it's been tested successfully and sales are growing in Japan. It's an NAI.. just like the two drugs that are approved.. and according to the CDC testing during 2009.. far more potent. An IV drug for seriously ill seems like a no brainer.. since Tamiflu has no benefit for them.
However.. I've been skeptical of the probability of success with the flu program for some time. Tired of all the posting of seasonal flu articles. .etc..
It's still the only IV drug I know of out there other than Relenza IV that could stem an outbreak of H5N1 because it's potent and gets in the system heavy and fast. All that said.. the probability of any success with this drug looks like an option on H5N1 and little more.
Hopefully.. they can find some value in this.. possibly by selling the rights to Shionogi for $25-$30M in order to them further development in ROW. . based on their testing/program.
Dear Commissioner Hamburg:
I write on behalf of the Infectious Diseases Society of America (IDSA) to further our ongoing discussion regarding regulatory challenges in the antibacterial and influenza antiviral drug development and approval pathways. You are well aware of the imminent public health crisis with the potential to affect our nation’s security resulting from the simultaneous increase in antimicrobial drug resistance and the decrease in the development and rate of approval of new drugs. IDSA appreciates the Food and Drug Administration’s (FDA) recent efforts in producing new antibacterial drug clinical trial guidelines. However, we are concerned that these guidelines still do not create feasible pathways for conducting antibacterial drug trials. In addition, pharmaceutical companies are continuing to eliminate or downsize their antibacterial research and development (R&D) portfolios. The current situation is untenable, and the remaining antibacterial R&D programs hang in a fragile balance. Similar challenges arise from FDA’s current approach to clinical trials design for influenza antivirals, particularly parenteral antivirals for hospitalized patients who are too sick to be treated with placebo.
We understand the difficulties that FDA faces in weighing the risks versus benefits in this area where the regulatory science is deficient. IDSA is supportive of FDA and sensitive to the agency’s constraints, but we remain deeply concerned. We jointly seek the same outcome: new, safe and effective anti-infective drugs. Unfortunately, at this time, the micro-organisms are evolving faster than we are.
For this reason, IDSA asks that you engage with the Institute of Medicine (IOM) to discuss options for developing a process to review the operational feasibility of FDA’s current approaches to the design of antibacterial drug and influenza antiviral drug clinical trials.
The IOM could: #$%$ the limitations and strengths of FDA’s current statistical approaches; provide new perspectives on approaches to balancing public health risk vs. benefit of decisions that must be made, even in the face of incomplete or imperfect data, and applied to the evaluation of the safety and efficacy of new anti-infective drugs; and make recommendations leading to more rapid improvements in regulatory science.
PAGE TWO—IDSA Letter to Commissioner Hamburg on IOM Engagement
Reaching out to IOM for its expertise at this time would be consistent with the ideals set out in
FDA’s recently released blueprint for “Driving Biomedical Innovation: Initiatives to Improve
Products for Patients”. In that report, FDA noted:
“During the HIV epidemic in the early 1990s, experts from many fields came together to rapidly
work through the science underlying the disease and devise programs for AIDS drug
development. The result was a relatively efficient development process and availability of
effective anti-HIV drugs.”
We need exactly that kind of initiative now in other areas of anti-infective drug development.
IDSA leaders appreciate that, despite less than optimal human and financial resources, FDA is
aggressively modernizing and clarifying anti-infective guidance documents. However, as IDSA
leaders have noted in meetings with you and other FDA officials and in our formal comments,
significant feasibility concerns persist with proposed guidances for Community-Acquired
Bacterial Pneumonia (CABP), Hospital-Acquired Bacterial Pneumonia (HABP)/Ventilator-
Associated Bacterial Pneumonia (VABP) and Acute Bacterial Skin and Skin Structure
Infections (ABSSSI). IDSA also remains concerned about the need for feasible guidances in
areas relevant to resistant Gram-negative bacterial infections, such as non-inferiority trials of
complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI),
organism-specific trials, and superiority trials. IDSA recently provided a similar #$%$ment of
FDA’s guidance for developing influenza antivirals for treatment and/or prophylaxis in our
comments submitted to the public docket on October 12. FDA’s guidances, in some instances,
appear to deviate substantively from standard clinical care and thereby may impede, rather than
facilitate, anti-infective drug development. ..
***The realities of patient care may not allow compliance with regulatory guidance.***
Our greatest concern is the statistical approaches the agency is employing. It seems that
many of the troublesome areas in the draft guidances result from, or are strongly influenced by,
the desire for unqualified clinical data, like mortality, that is easily analyzed statistically.
FDA’s current approaches particularly impact study designs where the infection/disease is
acute, life-threatening, and for which a placebo group has not been and cannot now be included.
The clinical reality in these patients is that successful treatment is measured by reduction of
fever, return of appetite, and normalization of biomarkers. We believe that statistical analysis
should include such clinically relevant endpoints as well as microbiologic endpoints addressing
the elimination of the infectious pathogen.. .. ..
I got to "Dear Commissioner Hamburg: I write" Then broke out in uncontrollable LAUGHTER. The "gift" - I KNEW HE'D COME THROUGH. MENTAL. MENTAL ALERT. WAR AND PEACE, VOL II "short form" just went up from ole WHACK-JAC, the basement boy. Dude, it's BK. OVER. DONE. You still don't get it do you? Get the model airplane glue- and just sniff a whole tube down- you're beyond hopeless.
Sentiment: Strong Sell
Ah yes, the basement boy speaks and all we hear is blah,blah, blah, blah. And then OF COURS he pulls a RANDOM, 100% MADE UP fantasy number out of his dumbed down butt, "possibly by selling the rights to Shionogi for $25-$30M in order to them further development "? Huh? $25 or $30 MILLION, FOR WHAT? How bout $50 bucks and a bowl of noodle soup with a fish head in it? WHO is going to pay $30 million for something that is WORTHLESS? You're dumber than a dirt clod dude. It's just that simple. Any other FANTASY "projections" you wanna toss out? We all need a good laugh for free.
Sentiment: Strong Sell
Skeptical???... you've never been skeptical about anything Stoney has said or done in your entire life especially repeating that ridiculous CEO comment about needing just one stockpiling order... I always said Pami was near worthless without a pandemic but I guess it's just worthless... I mean you have somebody else give you the development money and you still drop it... wow talk about incredibly worthless... I wonder what Map is going to do now that his absolute favorite drug has gone bye-bye and his searching third world countries for flu outbreaks ends up really being pointless...