Johnson & Johnson
(JNJ - Get Report)
submitted ibrutinib to the FDA on Wednesday for the treatment of two blood cancers -- mantle cell lymphoma and chronic lymphocytic leukemia. Ibrutinib has already been hailed as a wonder drug for B-cell lymphomas, so how quickly will FDA approve?
In all seriousness, the speed at which FDA approves ibrutinib will be interesting to watch as a test case for how the agency handles drugs awarded with the breakthrough therapy status, a designation designed to accelerate drug development and approval.
Ibrutinib actually has three breakthrough therapy designations, so investors expect FDA to review the drug and approve it quickly.
Let's try to quantify.
Assuming Pharmacyclics and J&J submitted ibrutinib to FDA on July 10 and the agency grants the drug priority review (eight-month review cycle), the approval would come on March 10, 2014.
No way it's taking that long.
John (above) thinks a three-month review is reasonable, which would place ibrutinib approval on Oct. 10. That's a reasonable expectation, perhaps a tad on the aggressive side.
The fastest recent FDA drug reviews/approvals were
prostate cancer drug Xtandi (102 days) and Vertex's cystic fibrosis drug Kalydeco (104 days), according to JMP Securities analyst Mike King.
A 102-day review period for ibrutinib would place the approval on Oct. 21. King expects a mid-October approval.
If FDA intends for breakthrough designation to have real meaning, drug reviews should be abbreviated. A three-month review period for ibrutinib sounds right, so call it end of October, early November to be conservative. Certainly, I'd expect ibrutinib to be approved before blood cancer experts gather in New Orleans in the beginning of December for the American Society of Hematology annual meeting.
contributor wrote a column in May looking at the
implications of an early ibrutinib filing
on the value of Pharmacyclics. It's still worth a read.
Here's a chart of Pharmacyclics' performance year to date. The stock is up 15% since the ibrutinib filing was announced.
Back to GTX:
GTx has not raised money through a stock offering since June 2011. The company did raise $19 million by selling the breast cancer product Fareston last year.
GTx's CFO Mark Mosteller sold 17,000 shares through the exercise of options on July 8.
And now, for the entertainment portion of the Mailbag: Hate Mail!
Kelvin G. writes, "You are [Bleeping] wrong about GTXI. I bet you and your crew bought today, [Bleep]hole."
JT writes, "Your days of slandering companies is over ahole. You will be investigated now! A group is already forming."
Jim: "[Bleep]hole... bad karma you [bleep] like you."
Adam (clearly an alias) writes, "Go [bleep] yourself! You bald headed, ugly [bleep], piece of [bleep]."
Steve R.: "You really are a dumbass and quite possibly the biggest loser I am proud to say that I don't know."
Enjoy your weekend, all.
-- Reported by Adam Feuerstein in Boston.