"What would be your target price for $CHTP on a CRL?"
stock price will fall if FDA rejects Northera on March 28; how much depends on what demands the agency places on the company in order to resubmit the drug for approval again.
Best case: If Chelsea only needs to negotiate final labeling for Northera and/or make minor fixes to manufacturing, the stock shouldn't drop too much. I hate making guesses on stock prices but let's say a 20% drop. [This assumes a relatively fast resubmission and a three-month response from FDA.]
Worst case: FDA asks for additional clinical data on Northera, Chelsea shares are more likely to fall 50% or more. Chelsea's market value may not fall as much if the company can use Study 306b results expected in third quarter. If an entirely new clinical trial of Northera is needed, the sell off will be more severe.
"Can you please remind everyone your take on $KERX? Just want to make sure you get your last bit of hate mail in!"
I'm no fan of
(KERX - Get Report)
, mainly because I see failure ahead for the phase III study of perifosone in advanced colon cancer.
On Monday, Keryx said that the 360th patient death needed to start the final analysis of the perifosine trial is likely to occur in March. If we assume Keryx is using electronic data capture in the trial, top-line results should be available in April, or May at the latest.
I won't rehash here the myriad reasons for why I
predict perifosine won't work
, but please revisit my previous columns on how Keryx runs afoul of the so-called
governing cancer drug development.
@matthewherper, my friend and Forbes drug scribe, asks,
"How does Max smell?"
To which, @kevinccc interjected, "With his nose. How do you do it?"
These days, Max (badly in need of a trip to the groomer) smells a lot like those wet towels you left crumpled in the corner of your room for a few days. That and a lingering essence of skunk, the result of an unfortunate encounter a few weeks ago. He's still the best dog in the world.
"2012 PDUFA or Adcomm event you strongly believe will be +ve or -ve, that most of the street disagrees with? (not VVUS, CHTP)"
I'm having trouble coming up with a contrarian opinion on an FDA drug approval. I was surprised that nearly all of my picks in
FDA Drug Approval Contest
line up with the consensus view.