House , SA News Editor Thinly traded micro cap Pain Therapeutics (NASDAQ: PTIE ) craters67%premarket on increased volume in response to its announcement that it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) seeking approval of abuse-deterrent REMOXY ER (oxycodone capsules CII). image sourceThe CRL informs the company that additional actions and data are required for approval. Managementsays the actions will take about a year to complete and could cost $5M. Specifically, to support a claim against abuse by injection, it will need to repeat an injectability/syringeability study using thin films of drug, smaller volumes of solvents, additional mixed solvents and alternative extraction methods and syringe filter. To support a claim against abuse by inhalation, it will need to repeat a volatilization study using the same thickness for each drug to increase surface area. To support a claim against abuse by snorting, it will need to conduct an intranasal abuse potential study in human volunteers (the company submitted animal data in its NDA) with drug applied directly inside the human nasal cavity. In addition, the agency stated that Pain’s clinical data to support a claim against abuse by chewing is not sufficient and it will need to submit a revised proposed label to indicate that the results from the study do not support the claim. The filing was the company’s third attempt at approval. The company will host a conference call this morning at 9:00 am ET to discuss the situation. Remoxy licensor DURECT ( DRRX -31.8%) is feeling a bit of pain as well.
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Cross section – Anatomy Transverse/Axial: Hip, Buttocks, Pelvic girdle, Thigh Cross section – Human body Axial/Transverse : Leg/Calf Display of the anatomic captions of the lower limb and use of this on-line atlas of human anatomy The “anatomical structures” tab allows the user to selectively display the captions of type: region, bones: skeletal system, joints, ligaments, muscles, muscular system, tendons, fascia, synovial bursa, arteries, veins, lymph nodes ganglia and nerves of the lower limb Dorsum of foot – Anatomy : Bones; Skeletal system, Joints of foot The “illustrations” tab provides access to individual chapters. Most exercises that hit the hamstrings, except for leg curls, will hit the flutes Gluteus maxims and minibus as well. bunion surgery day 6Follow your doctor’s guidelines. Many body-builders forget about developing the muscles at the front of the calves, primarily the tibialis anterior, which separates the indite calf from the outside calf and makes the leg seem much larger. The fibula, the other bone in the lower leg, is connected to the tibia below the knee joint. The deep posterior compartment lies deep within the back of the lower leg. Joint pain: Joint pain may occur because of a local injury but may also be due to medical conditions that can cause inflammation and swelling. Medical research has shown that about 50% of individuals who receive treatment experience a recurrence return of this type of infection.
26, 2016 at 11:19 a.m. Friend(s) Email The Washington Redskins ‘ secondary got into trouble early against the New York Giants . Redskins defensive back DeAngelo Hall suffered a torn ACL Sunday against the Giants , NFL Network Insider Ian Rapoport reports, according to a source informed of the injury. Hall is out for the remainder of the year. Cornerback Bashaud Breeland left with an ankle injury and was ruled out in the first quarter. Hall suffered a sprained right knee right before halftime and didn’t return. In addition, Redskins offensive lineman Shawn Luvao was ruled out with an ankle injury in the second half. Later, centerKory Lichtensteiger(calf) was ruled out in the second half. Here are some other Week 3 injuries we are tracking Sunday: 1.
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