If the conditions are relatively minor and easily resolved, the company is generally all too eager to make that clear straight away.
But up to this point, Sanofi- Aventis (which only two weeks ago was telling financial analysts and selected journalists it was "very, very confident" that FDA approval was imminent) has decided not to shed any light on the issues the FDA has raised.
They said only that they "will continue to work in close collaboration with the FDA."
This fuels suspicion that the issues might be quite serious.
In addition, the fact that Sanofi chose to put out news of the FDA delay in approving Acomplia late in the day on a Friday, after most U.S. financial markets had closed for the weekend and most of Europe was asleep was also "whiffy".
This is a real PR "sign" of bad news!
So, let's speculate a little:
Just this week investigators for the RIO-North America trial reported in the Journal of the American Medical Association that a year of treatment with 20 mg of Acomplia was associated with an average weight loss of almost 14 pounds and a waist reduction of 2.4 inches, versus just under four pounds and less than an inch in the placebo group.
Moreover, patients treated with 20 mg of Acomplia and calorie reduction for a year increased HDL cholesterol by 12.6% versus a 5.4% increase in the placebo arm (P<0.001).
In year two, 40% of patients maintained on 20 mg achieved "a weight loss of 5% or greater" compared with 19% of patients in the placebo arm (P<0.001).
Moreover, after two years, patients taking 20 mg of Acomplia were able to maintain a waist measurement that was about two inches smaller than baseline measurements, compared with a reduction of just 0.87 inches for those in the placebo arm (P<0.001).
Nonetheless, a high dropout rate (51% dropped out after a year) led F. Xavier Pi-Sunyer, M.D., of the obesity center at St. Luke's-Roosevelt Hospital in New York and colleagues to conclude that more study is needed to finally confirm a long-term benefit for Acomplia, which is the first cannabinoid-1 receptor blocker.
The FDA may have asked why did so many of the participants getting the full dose of Acomplia stop taking it? What happened that turned them off from taking Acomplia? What do we know about the weight and overall health of those who started on Acomplia, and then quit?
The Acomplia Report looks at the dropout figures in more detail.
Some patients reported depression and anxiety, which is a reason some doctors have urged caution.
In a recent research paper, Goldman Sachs predicted that, because of those CNS side effects, Acomplia would be approved only on the condition the company conducted a rigorous postmarketing surveillance program.
Looking at the ongoing trials, that are still recruiting, is interesting. These would be the earliest possible sources of new data.
Insiders' view: There are recent cases of bad news "approvable" letters: Crestor (their letter caused a delay of well over a year, asking for more safety data) and Pargluva (in reality, now a dead duck) spring immediately to Insiders' mind.
Sources: Diet Drug Report, Acomplia Report, New York Times