[Ed. Note: Dr. KSS writes about medicine and biotech stocks for the Irregulars. He chooses his own topics, and his words and opinions are his own. He has agreed to our trading restrictions. To see all of his column and his latest comments, go to his Stock Gumshoe page.]
[Author’s note: This commentary has been expanded from the version that appeared recently in the biotech discussion threads.]
Folks, let me make some comprehensive and tidying-up remarks about the situation at Corbus ($CRBP). Each event such as the one that just happens requires a burst of fresh due diligence, which I have done both on my own and in intense conversation with several people up-close to the situation that I trust. You’ve always got to take that bundle of al dente spaghetti that is your long thesis, heave against the wall, and make sure it still sticks there.
The hoo-ha mostly surrounds the fact that the endpoint on which Corbus boasts supremacy is an endpoint that wasn’t even in the original protocol. This, of course, is post-hoc analysis, where one must tread lightly. THE ONLY GENUINE CONCLUSION that can derive from this kind of analysis is that a new study, a more attuned one, is warranted. And that’s hardly a bad thing here.
I’ve been in the situation that Corbus is in—-newish company, still finding its way—and have been faced with drafting clinical trial protocols where you hope those turn out to be operas omnia, things covering ALL the bases, and yet most protocols do fall short. Possibly Corbus needs better advising as regards cystic fibrosis (CF). We cannot, however, let the perfect be the enemy of the good and shoot a company down for not having quite flown the plane into the stratosphere. And it’s with this in mind that in my view post hoc analyses should not be verboten and that in fact they energize, even galvanize, clinical research. Corbus has done nothing wrong, and they’ve done enough right things to date that I’d be the last to skeet-shoot at them now.
I’ll digress for a moment (you know I always do). I’ve said it til you’re sick of hearing it: Aurinia’s Neil Solomons, MD, is the best clinical protocol writer in a generation, and has crafted MC Escher-like protocols with deep-rooted signals, indexes, tripwires, flash points and so forth so that massive amounts of information can be extracted ...