CXS 0.00% 70.0¢ chemgenex pharmaceuticals ltd

Smokeandfire, Omacetaxine is very likely to be approved based on...

  1. 37 Posts.
    Smokeandfire, Omacetaxine is very likely to be approved based on the recommendation to the FDA to approve the drug by the Oncology Drug Advisory Committee (ODAC). ODAC will raise questions about drug safety, as the FDA's primary area of concern is the protection of the American public. ODAC will also raise questions about the methodology, biostatistics and conduct of the pivotal clinical trial. However, the FDA has as its primary mandate in Oncology the expeditious approval of cancer therapies, especially in areas of high unmnet clinical need. Chronic myeloid leukemia is one such area. This is because once patients fail treatment with Gleevec, there are no other effective treatment options. This is an unacceptable situtation, which will lead the FDA to "want to be able" to approve Omacetaxine.

    Share price of CXS upon approval will be $1.50 - $1.85 based on my valuation. SP will then trend down over time until sales traction is seen, which it probably will be with this strong management team. SP growth post approval will be based on sales revenue growth in USA and EU, each of which has approximately the same incidence per 100,000 population as the other.

    This is a well run company. So goog luck.

 
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