Orphan Drug Status doesn't assure FDA approval of the compound being evaluated, it confers certain marketing advantages and tax credits should the drug be approved.
Like most small biotechs CYTR will succeed or fail on the technology they employ. In CYTR's case the delivery system. The near term future of INNO-206 will be clear when they report interim findings of their ongoing 2b trial.
Like all biotechs this is a speculative investment, but I've watched many companies with similar strategies do well. The preliminary data look promising (no guarantee) but as I said in my previous post Abraxane uses Albumin as the entry vehicle in tumors and CYTR uses the same concept.
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