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.