Analysts thought the mixed vote at the FDA -- the panel was 9-6 in favor on both safety and efficacy issues but 10-5 against on approving the drug -- was one of the weirdest they'd seen. Jefferies & Co. analyst Corey Davis and his team said:
FDA AdCom panels are always tumultuous, but this was the most bizarre we've ever seen.Davis and his colleagues were already reeling from Forest's late disclosure of the suicides before the panel started. Jefferies believed the drug, for chronic obstructive pulmonary disease, could add $2 billion in annual revenues to Forest. Here's the tick-tock:
On April 4, things looked set for approval as the FDA's questions for Forest's presentation listed no obvious controversies.
On April 5, Forest's briefing documents disclosed a 6 percent level of psychiatric adverse events among Daxas takers, including three suicides and two attempted suicides. There were no suicides in the non-Daxas patients. Davis said in a note to investors on the day:
This was new but perhaps not surprising since the FDA has been looking for depression related issues in many new drugs recently.... Forest will likely have an explanation at the panel, but we have no idea what it will be.On April 6, Davis suggested that the deaths could be explained by patient histories and were low enough to be dealt with in the drug's warning label.
On April 7, the day of the FDA vote, Davis was more anxious:
The psychiatric profile remains the major concern to us. It is surprising that an increase in AE's like anxiety, insomnia, and depression â€" and especially the suicides and attempts â€" had never previously been disclosed by either company nor in the Lancet publication from last August. If we had been aware of it, we certainly would have had a more tempered view of the approvability for Daxas.
... we also think the FDA is agitated since it was not made aware of this effect until January when Forest proposed adding the new warning.Today, after the panel nixed the drug, Davis's commentary moved from anxious to sarcastic. In particular, he targeted Forest's management for their non-disclosure of the suicides. Davis began his note with the headline, "BTW, we forgot to mention a few serious adverse events":
We find it puzzling that the psych AE profile was never disclosed in the Lancet publication, nor at the ERS meeting last September, nor at the company's R&D day in January. Suicides have never been listed in any of the previous SAE disclosures.Given that Forest's stock tanked 12 percent on the news, investors might well ask, Why were those disclosures only made after investors had locked in the stock at a steady $31.50? It's now trading at $28 and change.