Cempra, Inc. (CEMP)

[agamemnus]

Prabha is a scientist.

She founded the company. She took a lot of risks. She did a lot of work. The early trials were run perfectly. But she rushed into the finish line unprepared, and bungled the NASH and COPD trials (by adding patients that were specifically excluded, for one). Ultimately, there were a lot of warning signs that Cempra wasn't prepared for the adcom.

But those warning signs were not what you might think. The drug is 100% safe, but it takes a *lot* of research to really know this. On the outside, it is easy to be led astray and say "oh it's like Ketek so it won't be approved" -- which is what the FDA said basically, but it does not make it scientifically correct. So it is not a warning sign. It is a red herring that just happened to be what the incompetent FDA also latched on to because of incompetent management.

So if you have followed that "surface" warning signs you wouldn't have lost money on the big drop after the briefing docs came out, but you'd be only *accidentally* correct. You wouldn't deserve a pat on the back.

The "real" warning signs were there, though:

1) No one -- not investors, not sell-side, and NOT THE MANAGEMENT -- alerted anyone else about the Wockhardt factory issue. Wockhardt's deal with Cempra was public. Wockhardt only has a limited number of factories and the one that got the import alert (which is public info, Wockhardt itself PRed it, and there were news items on it) was I think the only one that was available to export to the US. Yet everyone associated with Cempra completely ignored it and moved the stock from 18 to 24. (I wasn't paying attention to the company at the time...)

2) The approved compensation structure gave management bonuses upon completion of certain steps in the NDA, equally weighed. It was not aligned with reality where none of those steps except the last one (approval) matter.

3) The announcement of the adcom itself. The FDA often does these for new drugs, but not always. The price did not move at all and almost no one cared -- you can see that there are only two comments on SA with concerns. One of them is mine: https://seekingalpha.com/news/3206223-ad-comm-november-4-cempras-solithromycin#comment-73062146.

4) The hope that the import alert would be lifted in time for the CC in the October CC shows Cempra management was clueless about what was actually going on in the factory, or lying through their mouths. Again -- either Wockhardt or Cempra was lying because the horrific 483 observations came out in something like November 2015!

After the adcom, if you remember, Cempra stock was actually up on decent volume about 35% in pre-market after the adcom and got shorted/sold down way below on that day. So not everyone agreed.

FDA could have easily approved. Remember, that was really a 9-4 vote on approval. And then the FDA bungled the meeting minutes very badly(and refused to fix them, despite my many phone calls and emails).

So I am leaning on the side of CYA along with good old jealousy at a fellow Indian.

In any case, this company is now severely, ridiculously undervalued... especially with the Melinta merger and its Baxdela miracle drug!

...also,... did I mention Japan is running three solithromycin trials?

http://rctportal.niph.go.jp/en/detail?trial_id=JapicCTI-163438
http://rctportal.niph.go.jp/en/detail?trial_id=JapicCTI-163439
http://rctportal.niph.go.jp/en/detail?trial_id=JapicCTI-163467