FDA has provided follow-up on the Phase III program investigating Isolagen's Therapy for the treatment of moderate to severe acne scars. The FDA reiterated that there are no safety issues that would prevent the initiation of the proposed studies. However, the FDA asked the Company to further clarify certain protocol issues and raised questions related to the acne scar Evaluator Assessment Scale and Photo Guide. The FDA recommended that in order to address these issues, the Company should conduct a Phase II study; therefore, the Company will propose modifying the ongoing Phase III Study IT- A-008 as a Phase II/III study (as discussed further below). The FDA requests are specific to the acne scar clinical program and do not impact the Company's ongoing, pivotal Phase III clinical program evaluating the Isolagen Therapy for the treatment of nasolabial folds, or wrinkles.Isolagen's two randomized, double-blind, placebo-controlled acne scar clinical trials (IT-A-008 and IT-A-009) of approximately 120 patients eachwere designed and powered as Phase III studies.

Interview : Michael Bay

I know my colleagues are going to have Transformers'' questions, but I wanted to know your reaction to 'Hot Fuzz' which was so inspired by 'Bad Boys 2', and that you said that you were offered 'Die Hard 4' and I was wondering if this hadn't come together would you have considered doing that?

MB: Die Hard 4, no, I don't think so. Hot Fuzz, I haven't seen it yet, because I was finishing this movie. It's really hard, the end of your post schedule is such a grind, seeing a movie is like the last thing you want to do when you go home. I thought this would be an easy post, on our budget we had a hiatus scheduled in here, because I said, "Oh, my God, I have the longest post schedule," I didn't think the robots would be that hard, but I was directing them all the way to the very end.

Dangers Work Way Into Office Romances

If the relationship ends on bad terms, do you think your now ex-sweetheart will tell human resources you made unwanted advances? A harassment suit will definitely impact your career. Be proactive and join a professional association - or two. They will provide the opportunity to socialize and advance your career.

Return To Yesterday's News

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Silverton may sue doc over laser treatment

British news presenter Kate Silverton is threatening to sue the doctor who conducted the laser skin-rejuvenation procedure that temporarily disfigured her.
Silverton, 37, underwent the treatment to have acne scars removed and to improve her skin tone; however, her face ended up swollen and covered in painful sores and lumps, the Daily Telegraph reported.
She was also forced to take two weeks off from her job at the BBC, the report said.
Although Silverton is now back to work, she told her attorneys to begin proceedings against the Jan Stanek clinic in London.
"It's been awful. I went in to get some minor scarring on my cheeks treated. I was told it would be a routine procedure and I'd be back to work in days. The treatment, however, caused a massive skin reaction," Silverton told the Telegraph.

Who's Blogging

In a scathing report on 11 deaths last year at the District's St. Elizabeths Hospital for the mentally ill, an advocacy group for the disabled told city officials yesterday that medical neglect resulted in "needless pain and suffering" for most of the patients "and may well have contributed to deaths from treatable conditions."