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Re: DewDiligence post# 246

Wednesday, 09/21/2005 6:58:38 PM

Wednesday, September 21, 2005 6:58:38 PM

Post# of 52042
Dew, Yes, GTCB's very high risk doesn't come from the science as was the case with PARS and CTIC (clinical efficacy or lack of efficacy of the drug), but instead from the reluctance of politicians and regulatory bureaucrats to stick their necks out unnecesarily. By approving the world's first transgenic drug, they are putting their own necks on the chopping block if something goes wrong down the road. In a Mad Cow/SARS world, fear and perceptions can have more weight than logic and science. In such an environment, approving this first transgenic protein is a huge step, and the approval will open the door for many more drug products derived from animals. It's only natural for regulators to err on the side of extreme caution when making such a decision. They really have nothing to gain by rushing the decision, and a lot to gain by stalling as long as possible. Seeing that GTCB is such a tiny company with very limited resources, the regulators could easily just delay until GTCB runs out of money - then the regulator's problem goes away. While this underhanded scenario may not come to pass, I wouldn't put it past the buggers to try it.

All I'm saying is be careful not to put TOO many eggs into the GTCB basket. Odds-wise, one would have to say that it's probably 2 to 1 that there will be additional delays. It would be different if GTCB had plenty of cash to wait out the process, but I wonder just how long can they hold out financially.
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