Cempra, Inc. (CEMP)

[Johnny_C]

No... They really really pissed the FDA off. Keep in mind that the FDA on their own initative fastracked this and gave it needed drug status.

She must have really been a dumbf**k when it came to the FDA. They have basically told CEMP management to screw and don't come back. She certainly misrepresented her meetings with the FDA and completely failed to address the safety.

With Serepta, people lobbied FDA and they reversed. I doubt CEMP will have a chance to do that.

The new jack*ss CEO could not even answer the question whether the 9000 study is 4500/4500 or a 9000/9000 study. either one is near impossible for these dimwits. Further they stated they the Europe and japan trials will continue, but what are the odds of success there given the FDA response letter.

It is baffling because so many doctors liked the results and it is a needed drug.

if Company continues they will just blow through that money and hope to hit a homerun with gonorrhea drug. The options management has are worthless so they could run the clock out. Analysts will not trust them again, ever.

even if approved the FDA stated it will be heavily labeled (most are anyway) and it will strictly a second line drug, the patient could be dead by then. My hope is this is a strong enough signal to sell the company and let a real team handle this. Hopefully with good safety results a new company can negotiate with the FDA to soften the determinations of the response letter.

Glad we sold it twice and had a free ride this last time.