Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-475

  1. 6,957 Posts.
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    Your logic is flawed. Just because the components of the new assay already presented to FDA and accepted (as evidenced by FDA now determining the GVHD001 trial is a well controlled trial), is not in the public domain, is irrelevant. There are obvious reasons for that.

    Be careful thinking sciency types are rare and clever and somehow their insights take precedence over other evidence in determining whether an ASX announcement has any change in the company status. Do you really think the current volumes represent dumb money? Are they retail volumes? Do you think the weight of money behind the SP run has no access to 'sciency types' dare I say more clever than HC contributors? Do you think they don't have access to regulatory experts who can interpret what "after additional consideration the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission" means?

    Investing, is unfortunately not a pure science. That's why amateur egg heads usually don't make their fortunes on the stock market.

 
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