Presentation Number: 143
Presentation Start Time: 1/29/2014 1:50:00 PM
Title: Anti-Viral Drug Development: Case Study ST246
Author Block: Dennis Hruby;
SIGA Technologies, Inc., Corvallis, OR.
Abstract Body: ArestvyrTM is a smallpox antiviral drug that is in late-stage development for use as a therapeutic for symptomatic patients, prophylactic in infected but non-symptomatic patients, and for concomitant administration with smallpox vaccines to improve their safety profiles. Arestvyr is an egress inhibitor which prevents the formation of the EEV forms of orthopoxviruses. It has demonstrated excellent post-exposure efficacy in a large number of animal species that included mouse, ground squirrel, prairie dog, rabbit, and NHP challenged with a variety of different pathogenic orthopoxviruses including vaccinia, cowpox, rabbitpox, ectromelia, monkeypox and variola. In clinical studies, the drug appears to be safe and well-tolerated. Once a day oral dosing provides blood exposure at or above that which has been shown to be protective in animal studies. Following robust and iterative discussions with the regulatory authorities, a clear and achievable pathway has been mapped out for the approval of the drug for use as a therapeutic for symptomatic patients, and SIGA and its federal partners are in the process of executing this plan. Based on the data obtained to date, the U.S. government has awarded a contract to SIGA for the acquisition of two million courses of Arestvyr to be added to the Strategic National Stockpile. . Work continues on the development of additional Arestvyr formulations and towards approval of the drug for additional indications.
" Following robust and iterative discussions with the regulatory authorities, a clear and achievable pathway
has been mapped out for the approval of the drug for use as a therapeutic for symptomatic patients, and SIGA and its federal partners are in the process of executing the plan."
You deceived with your prior bash re approval possibilities for ST-246 & with your last defensive post you trump the intentionally ignorant bashing deception of that prior post.
You cited that there is ONE & ONLY ONE path to approval in the prior post.
You were called on that ignorant conclusion & you rebuttted with a repeat of that ignorance by citing the obvious that you can not inject humans with smallpox, though THE CURE worked on one soldier(it actually has worked on at least 5 humans which you neglected to mention).
You implied therefore no approval was possible.
You were WRONG with the prior post & you are WRONG with ignorant defensive post.
Dr. Hruby's statement rules, SIGAKING's citations are from the regs, but others can provide other scenarios leading to approval......rapid approval.
The award of a $2.8B contract for THE CURE by the USG signals that anyone suggesting NO APPROVAL or additional animal studies before approval does not know his navel from his #$%$,NWAMLN?
Could it be that politics is delaying that approval?
Like the politics that was applied to reduce the USG award?