I spoke at length with Steve Carter a few weeks ago.There have been a few delays but Phase I and II are being organised.Phase I will involve 30 people with late stage cancer of various types.Only one injection is needed to check for toxicity and safety. (Just a formality as it has already bee n used on Special Access patients).Stage II will involve 30 patients with advanced mesothelioma and metastatic melanoma (spreading lung cancer).There will be 15 in each group and they will receive 6 injections in this trial to prove efficacy.
Having read about "fast tracking" from previous announcements, I asked if this was official. His reply was that it was in black and white in the Minutes of the Meeting with the FDA. So fast tracking and rolling assesment have been approved. I asked many more questions too many to post. Look at the webpage www.solbec.com.au . Annual Report 2002 has heaps of info on whats going on and comparing BEC2S to current chemotherapies. If you want correct info contact Steve Carter.]
Still waiting for TGA approval for testosterone based HRT. Have been waiting for over 1 year now TGA going at a normal government dept pace of dead slow!
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