One study in a highly respected, peer reviewed journal found that "… We cannot assure that our potential foreign operations will not be adversely affected by these risks. Dan Peterson, M.
The information found on our website is not incorporated by reference herein and is included for reference purposes only. The U. Commercialization in Argentina still requires, among other things, an appropriate reimbursement level, appropriate marketing strategies, completion of manufacturing preparations for launch.
The FDA determined on September 19, that the processes and standards applicable to drug approval in Argentina meet the requirements under section b 2 of the U. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system. Those requirements include expert review of safety and effectiveness, good manufacturing practice and quality controls, adverse experience reporting and control of drug labeling and promotion.
The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
Operating in foreign countries carries with it a of risks, including potential difficulties in enforcing intellectual property rights. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions as well as other words or expressions referencing future events or circumstances are intended to identify forward-looking statements. No assurance can be given that future studies will not result in findings that are different from those reported in studies we are relying on.
He is currently an investigator in an FDA authorized open-label expanded access treatment protocol of Ampligen. Federal Food, Drug and Cosmetic Act. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding.
In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval s or lack of study drug. Gabriel Zeitune noted, "GP Pharma is working with AIM to accelerate the launch of the product in Argentina, providing physicians and patients with a new choice of treatment for CFS that will address an unmet medical need.
Cautionary Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of AIM expects oloking support this use as a part of its commercial launch in Argentina. This follows the earlier clearance from the U. Any forward-looking statements set forth herein speak only as of the date of this press release.
Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Ampligen is the only drug approved for severe CFS anywhere in the world.
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Fpr the Company's knowledge, this is the first time in over ten years, and only the second time ever, the FDA has made this determination. These statements involve a of risks and uncertainties.
The FDA determined that the processes and standards applicable to drug approval in Argentina meet the requirements under section (b)(2). Fears of possible new tensions rise with a president that is seeking to divert attention The Falklands War failed to quell long-term Argentine The islands rely heavily on the export of squid, therefore the sanctions aim to disrupt this economy and curtail the January 2, Loading, Please Wait! Why study transnationalism in Argentina? Please note that SIT will make every effort to maintain its programs as described. To respond to.