Frankly after 102 did not meet its end points, to be honest, I was so upset with HR that I proceeded with a post that indicated he should now be fired. I decided not to publish it because of all the unrelated #$%$ that Kennedy and his aliases pollute this board with by not giving him more reasons to publish his unintelligent posts.
In a post, however, I did raise a question that indicated my displeasure with the failure.
Through my posts for the past 7 years I have repeatedly complained about the incompetency of HR only to be lambasted by Multi while he was alive (may God bless his soul - he always did have good intentions though) as well as a few other long term holders.
All along HR and his teams had tooted 102 for its low side effects and for its efficacy to be at least as good as Irinotecan. I do not understand why they moved the goal post higher than that only to end up in failure. One always aims at the minimum and if the results end up better, that is gravy. Even though questions have been raised as to why the higher efficacy requirements were included in the study, HR has not responded as far as I know..
It seems to me if the FDA required higher efficacy for 102 then 102 is dead. If FDA did not require it and the higher efficacy inclusion was HR and his team's idea then they should be fired.
HR and his incompetent scientific and medical officers, in failing several times including not partnering 102, failing 181 for faulty design, and now with 102 fiasco have caused us a lot of pain.
Frankly, the only reason I am sticking with this stock is because of the tremendous potential
in its technology. As far as this management is concerned I believe it is time to give HR his pink slip and hire a competent person to run the show.
" Do not sell here. If you sell you are throwing away 50,000 dollars (on 100K investment). I do not know any other big-cap biotech which can appreciate so much in a few months."
Heed Third's advice. He save me a lot of money. Last year, when I got very impatient with VRTX management I sold all of my VRTX shares when it was at $50+ ( mind you with a good profit since I have been a VRTX investor since its inception). I announced what I had done and why. Thank God Third came to my rescue and posted a comment about my decision -- something similar to his present post -- that got me out of my emotional decision to sell and the fact that I would lose a golden opportunity with my decision. On the basis of his post I bought all my shares back, albeit at a bit higher price, and now the stock is over $110.
Thank you Third for your wise advice.
"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.