SA News • Fri, Nov. 21
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Fri, Nov. 21, 12:46 PM
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Thu, Nov. 6, 10:52 AM
- As expected, the FDA's Center for Devices and Radiological Health informs EDAP TMS SA (EDAP +2.3%) that its Ablatherm-HIFU PMA is not approvable in its current form.
- Consistent with the feedback from the Gastroenterology and Urology Devices Ad Comm meeting, the regulator recommends a modified indication for use in a population of localized prostate cancer patients that have greater risk of morbidity and/or mortality from the cancer. It also made recommendations pertaining to the use of the company's European registry, along with safety data from the U.S. IDE, to support approval for the modified indication. EDAP will have to generate additional data and analyses to comply with the FDA's requests.
- In order to continue the process, EDAP must submit a major amendment to include the additional information no later than April 29, 2015. It may extend the review period up to an additional 180 days after submission.
- The Gastroenterology and Urology Devices Panel voted against approval in late July.
Tue, Nov. 4, 12:22 PM
Fri, Oct. 3, 1:53 PM
- The Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee voted against recommending regulatory approval of SonaCare Medical's Sonablate 450 for the treatment of recurrent prostate cancer in patients previously treated with external beam radiation therapy. The device utilizes high intensity focused ultrasound (HIFU) to ablate tissue.
- The panel's rejection was due to the fact that Sonacare's clinical trial data were based on an interim analysis of the first 100 patients in a planned 200-patient clinical trial. The company obviously believed the data were compelling enough to proceed with its submission prior to the conclusion of the study but the reviewers felt otherwise.
- The panel voted 7-3 against (1 abstention) recommending that the treatment was safe if used as intended; 9-2 against recommending that the treatment was effective if used as intended and 10-0 against recommending that the benefits outweigh the risks.
- Briefing docs
- Prostate cancer therapy-related tickers:(TKAI -2.1%)(MDVN +1.2%)(NYMX +4.8%)(EXEL -0.3%)(PGNX +2.8%)(MRK +1.8%)(ADXS +2.7%)(EBS +1.8%)(EDAP +3%)(ISIS +2.1%)(NVGN)(DNDN +0.7%)(ISR +1.4%)(OGXI +0.4%)
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Mon, Jul. 28, 1:15 PM
- Shares of EDAP TMS S.A. (EDAP -21.5%) drop on a 3x surge in volume. Earlier today, the FDA released its briefing documents for Wednesday's meeting of the Gastroenterology and Urology Devices Panel. The Committee will discuss the company's PMA for the use of Ablatherm HIFU as a treatment for prostate cancer.
- Investors appear to lack confidence in a positive vote. The agency's comments in the documents imply that reviewers have numerous questions/issues that need to be resolved regarding its clinical trial data.
Mon, Jul. 28, 12:45 PM
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