"I expect it by April/May, there has been no adcom meeting which indicates early approval"
And yet it is trading about $120. One wonders if it is because investors believe it may not be approved. With the results meeting its end points and meeting its statistical significance and no scheduled adcom, it is crazy that VRTX is not trading at at least $150.
"Looks like your wish is being granted"
Not really, as I said it in my post I was hoping it would go down $6 so I could really load up. Nevertheless, I added more shares at low 11. That was a gift. Hope it would go down more so I could add.
Any one care to give an opinion as to whether the value of this year's pending approval of Ivacaftor+Lumacaftor is already baked into VRTX's PPS? Is there much of an upside after the approval?
" I think the market is seeing the Phase 3 of 661 as only beneficial if it will be able to reach heterozygotes, "
Why 6% and not 4% improvement?
I thought the main reason for 661 was to increase the pool and if 661 showed a bit over 4% improvement doesn't that increase the pool nevertheless?
For 661 phase 2, did VRTX indicate what % FEV improvement it would consider a success? Did the study have an end point guideline? Did they mention the 6% as an expectation?
"What happen to all those other ongoing trials that include Irinotecan ... gone? "
If the main purpose was to show 102 had less side effects and was at least as good or better than Irinotecan, why didn't the trial design for 102 had arms that included 102+TPC vs Irinotecan+ TPC? That would have been comparing apples with apples.
"The original intent was prolong exposure and to lessen the side effects"
So I am curious as to why that was not the main focus for establishing statistical significance. Was that part of the miscalculations that have happened several times by NKTR CMOs when they designed they designed the drug trials?
Can someone tell me why 2.1 month longer survival was not considered statistically significant even though the experts said an additional 2 month of survival would be a greate achievement?
Was it because the bar was set too high? And if so who decided on that -- was it NKTR's CMO or was it set by the FDA as a minimum requirement?
"Does the patent for Ivacafter protect against someone using deuterated Ivacafor?"
Yes it does. Apparently, you do not know much about patent laws. The only time a compound can be altered and sold as an improved version without the patent holder 's permission is when the patent has EXPIRED. An example is NKTR-102 is an improved version of Irinotecan whose patent expired a while ago and now is a generic drug.
They "barely missed the P value by a little bit."
Side effects were much lower with 102 and the liver and brain patient did show a significant improvement over the control group. That is good enough for me.
I do not mind if it falls $6 or more tomorrow because I am going to buy A LOT. If it gets hit only a few bucks I will buy a moderate amount.
This is a lifetime opportunity to buy a stock with a big pipeline at reasonable prices!!
The title of your message is correct, but it is something that has not happened. The FACTS are that the insurance companies ARE already paying for the drug. Apparently, you are not well informed. I suggest you read the available facts and then if you have any common sense cover your short albeit at a loss. But that is at least better than losing a lot lot more if you wait too long. Oh and BTW don't tell me you are not short or you are not trading options!