PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[king oil]

I never saw any issues with the clinical trials. The science looks really strong. Given the opinions of experts, some of whom post regularly, as well as the FDA's acceptance of the BLA and the ongoing success of the phased trials, I would be shocked if the rejection is based on the outcome of the trials. I think it's far more likely that there are issues with the manufacturing and/or labeling. I think that would explain why the companies aren't dropping the drug. On the contrary, some patients continue to use the drug which certainly wouldn't be the case if there were any safety issues.

The red flags I have seen and been fairly vocal about on this message board is the lack of transparency and at times raw incompetence of the company's management team. The recent dilution so close to the PDUFA was a giant red flag. If management had confidence in approval they would have waited just a few months for the milestone payments, or if necessary, wait to sell more shares at a far higher stock price. Instead they rushed to sell shares prior to the approval date. I don't think this was just a lucky decision. The lack of transparency continues even today. The press release says nothing about the reasons for the rejection. Apparently they regard investors as just an annoyance. A group that provides the funding the company needs but doesn't deserve any information. This company's senior executives don't deserve to keep their jobs. If I were Chiesi I'd demand big changes and fast!