I disagree with some of this.
IV is not more profitable because it's a numbers game. Cempra had estimated that 80% of their revenues would be from oral.
"If they do get approval with oral they still are a second line antibiotic."
You are assuming facts not in evidence. There is absolutely no reason to believe that it will be a second-line antibiotic. There will be another PDUFA. As it is, the adcom's consensus was not even close to what the FDA wanted in the CRL. A couple thousand, like many "no" (to safety) voters said, is not 9,000. One "no" voter said he's not voting "no" for approval. Another said he would have voted "yes" if Cempra had a definitive safety plan in place, which was really stupid because these things are not determined before the adcom.
The meeting minutes were absolutely misleading and inaccurate in summarizing the transcript, as well.
The FDA division head in the anti-infectives division has an agenda or is completely incompetent. She will not be able to twist the facts once a second adcom is convened. Many of the (also incompetent) adcom members, with a 6,000 person safety study, would be unequivocal.
And Cempra's CEO was incompetent in that meeting as well.
But solithromycin, the drug, is valuable and safe. I have no doubt about it. Nor about the fact that solithromycin will replace azithromycin and be a multibillion dollar drug.
Totally agree call was hugely bungled. They had over a week to prepare. At least 9 days. Def. think many ex-US partnerships is a sign Baxdela has good value. It stands out in safety and efficacy as I mentioned on SA. There's still the warning label which all drugs in this class have. I wish they could show the FDA's research on the subject though, in order to reflect how rare those side-effects are.
And even though they are stupid rare, they are also very serious (sometimes). Serious liver macrolide side effects are a magnitude rarer although possibly more serious. And I still think solithromycin is the safest of all the currently-available macrolides.
Finally, I'll say this: maybe management will be happy with the scraps they get as severance/golden parachutes. But they need the price to go way up to make anything on their options, so maybe they will finally work on that towards the end? Although, I guess they could always issue themselves more options.
