FDA: Again, a very good course of action, sir. Meanwhile, we just pulled your case and we will start reviewing your material immediately .
AMRN: Thank you for your time, then. Goodbye, and we look forward to hearing from you.
FDA: We will speak with you anon. Goodbye.
AMRN: Sorry. So, you probably remember now that you said that you would have news for us today, January 15? The market is going crazy over our shares and our investors are being very short with us, demanding some information…
FDA: We are totally unconcerned with any of that.
AMRN: But you did state that we today was a deadline for you to rule on…
FDA: We are the FDA. We set the deadlines…
AMRN: Right, that’s what I am saying.
FDA: …and we can cancel deadlines arbitrarily that we arbitrarily made.
AMRN: Did you cancel the deadline for ruling on our SPA being reinstated?
FDA: No, if we canceled the deadline, we would have told you. The decision has been delayed.
FDA: Well, actually, we just forgot it was today . Think of it as a little April Fools’ joke.
AMRN: But today isn’t April 1.
FDA: I know that, sir, but if it were April 1, where would the joke be? You see, a critical element of humor is the element of surprise. If this were April 1, it wouldn’t be funny. No, an April Fools’ joke in January is much funnier .
AMRN: I fail to see the humor, but I realize that my judgment does not matter.
FDA: Now, sir, you are coming around to the correct state of mind. Look, you’ve been a real sport about all of this, so I’ll let you in on a little secret. It isn’t that we failed to come to a decision, it’s just that we forgot about this whole appeal thing, what with the holidays and all. You can understand that.
AMRN: I do understand. How long before we hear from you, do you think?
FDA: Don’t worry, sir. The delay will not be significant.
AMRN: What does that mean?
FDA: Since lowering triglycerides does not make any difference, no delay is significant .
AMRN: We can’t tell our investors that….
FDA: Sure you can, just tell them that there will be no significant delay.
AMRN: OK, we’ll take your advice.
AMRN: This is Amarin Pharmaceuticals. We were expecting a phone call today regarding the FDA decision on our SPA, and, well, it’s 3:39 Eastern time and we still hadn’t heard anything yet so we thought we should call.
FDA: What is this in reference to?
AMRN: You know, our drug Vascepa, triglyceride lowering, cardiovascular health..... that kind of thing.
FDA: Yes, what about it?
AMRN: Well, you know, you cancelled our SPA for that drug and…
FDA: No, sir, I’m sure you are mistaken. We wouldn’t cancel a SPA since pharmaceutical companies depend on the SPA process to remove some of the uncertainty inherent in bringing a new drug forward for approval. If we were to nullify a SPA, it would throw cold water on the whole industry. Companies and investors would become much more reluctant to put their money at risk for clinical trials.
AMRN: I’m really quite sure that you did cancel our SPA. You put out a press release about it.
FDA: Oh, that is a different story. A SPA is important but a press release is very carefully crafted. . You must have done something very naughty to have your SPA yanked .
AMRN: The FDA said that there was evidence that lowering triglycerides in the patient population covered by our ANCHOR trial even though Vascepa lowers triglycerides without raising bad cholesterol. We and others have shown that the evidence that you brought forward was for a different patient population…. Is any of this sounding familiar?
FDA: Well, of course. Why didn’t you mention the press release to begin with? Do you expect us to remember every little mom and pop biotech that comes by with a new drug? We need context.