I think Kynamro is approved, but, when they said "discussing labeling" I thought it through
I think there will be some requirements for a Phase IV type of approach. A lot more close watch on the patients and reporting back. So the good is they start to revenue the antisense product....finally....the bad is, with restrictions that maybe raise some doubt which will be solved with more data. "more data" is my fear...a want for more info before letting go of the ropes.
We will see very soon now. 48 business hours away. Good luck to all longs, the dung pile for the shorts.
bar.....My track record of predicting FDA approval is AWFUL. I own some Feb $11.00 puts therefore it will probably be approved. The efficacy of the drug is not in question but IMO the fact that this HoFH population is so small is the biggest thing that ISIS/Genzyme/Sanofi have in their favor at this time. The safety issue become far less important. However, as an NME (new molecular entity) this drug lacks history of long term effects. I have spent HOURS carefully reading the briefing documents and I am truly amazed that the panel voted in favor of approval. If YOU read them you'll lose count of how many times the FDA reviewer uses the words/phrases, 'it is unknown, ' or' unclear '........Go to the last page of docs, page 242 to see "The association of mipomersen with....tumors is intriguing...since the Agency is aware of another PS ASO that is associated with similar tumors in the mouse...." The tumors appear at less than one human dose, the greatest amount at only 2X the human dose. The "expert" panel votes in favor of approval. Scary. I could go on and on............Good luck to ALL us gamblers. We'll need it.
Appreciate your thoughts. I was true to my words...I starting thinking about the old freudian slip..."discussing labeling". I could take that to mean the FDA wants to approve, they collectively need to have an antisense drug out there to gather more data and find out, once and for all, if, for example, the vector in use causes cancer. Or the antisense construct itself?
He could have said "we already discussed labeling and agreed to the wording" but if you examine the statement, it was intended to make investors *think* "well, why would FDA discuss labeling if they are just going to decline approval" and indeed, it makes sense to think FDA is going to approve, BASED ON THAT STATEMENT. But it also makes sense to read in that it was not a rubber stamp. So if there are mines in the discussions, I think its going to be a Phase IV and slightly disappoint the investors. Stock will drop a little.
The good news will be, FINALLY, an antisense product will be out there where the recipients will not number in the single digits or tens... If they were truthful and site irritation as well as flu like symptoms have been eliminated, they will quickly have some solid numbers to glean data from. The world will expect the efficacy to hold true. All will want to see, is Cancer tied to the drug, for whatever reason. That will take, IMO, perhaps 1000 or more patients and I feel those who have not taken statins much, should be in their own respective study group. Statins cause cancer. So its hard, when a patient is say 45, and has been using statins all their life, to peg Kynamro. It may not be, even with a high incidence of cancer because the patients have been through a lot of drug treatment, in most instances.
Time will tell. FDA outright denying the license and trashing the trials seems surreal. Its Sanofi at the helm here, and Biogen making a recent investment. It just cannot cause cancer as easily as a few industry comments make it seem. These are whole companies, granted, biased companies with skin in the game, but still...if there is enough safety seems like a crime to keep it from the patients.
Well, holding my breath now, like any interested investor...Dark may have the last laugh, but it seems a failure here will do nothing but hurt everyone.