Jefferies has had it wroing the entire time so I guess they feel it is too late to change now. Pirfenidone's patent runs out in 2012, I believe. They do have orphan status but that can be broken if the molecule can be developed with fewer side effects. Pirfenidone does have side effects that can be minimized with changes to the delivery technology. I think the stock is ahead of itself but that doesn't mean some large pharma doesn't grab it without thinking.
FDA AdComm panel voted 9-3 in favor of approving pirfenidone for treatment of IPF; PDUFA date, May 4th; we continue to view potential approvability low with current dataset.
AdComm panel voted in favor of pirfenidone approval; ITMN shares will likely trade up on expectations for highly likely approval (>85% probability). However, we view FDA risks remain (e.g., delay in PDUFA, requiring additional data), thus skewing risk/rewards towards downside. Recommend taking profits, especially on share strength.
Eun K. Yang, Ph.D., (212) 284-2264 eyang@Jefferies.com
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