SBP solbec pharmaceuticals limited

SBP infor for Manila

  1. 350 Posts.
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    Re belief that the further testing of animals in Canada as not being a positive announcement is quite wrong. This is the next step in commencement of human trials in US in early 2003 and is necessary for FDA approval.At present human trials are about to commence in Australia and once started will not take long.The lead time to commencement of these trials is due to red tape, waiting for approvals from Ethics Committees etc.
    The FDA have agreed to fast track BEC which means no stage 3 trials are required.
    Recently the drug Eloxatin for colorectal cancer, was approved by the FDA within 7 weeks.
    This drug is one of the new breed of "blocker" drugs that have to be used in combination with other chemotherapy drugs to have any effect. Unlike BEC they do not kill the cancer cells but block the growth to the cancer tumour to a certain extent. Iressa is another such drug.
    Read the attached FDA site for an explanation of "Fast Track" and the rolling application procedure. Note that the FDA say that this drug Eloxatin has very little effect used on it own and also that it has been approved "even though long term benefits such as increased survival have not yet been demonstrated."
    Check out all the other cancer drugs that are being trialled, how they work, their effectiveness in killing cancer cells, then check out BEC, do your own research.
    http://www.fda.gov/bbs/topics/NEWS/2002/NEW00825.html
 
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