Oracle, biotechs are always a speculative investment at varying degrees of risk right up until we see results of sales. Of course it is much lower then than when the product was still in the concept stage.
Your acceptable level of risk is the start of trials. Well, trials do fail so risk is still a factor.
Our product is a cancer test on a mass analyzer and my level of risk for a large investment became acceptable when the product showed prood of concept at the ISOBM. Even thogh studies showed it previously worked, it was not acceptable to me when it was an unmarketable RIA test.
The level of risk will become even lower when another partner is signed.
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