This is the information from one study. Other hospitals studies were even better.
Complete resolution - 21 patients - 19% patient disease free
56 of 61 patients - Strong Partial resolution
Stable - newer enroll patients 21 of 23
ASCO now has these findings. You can email them. The results are outstanding. I now think that EXEL wants to produce 2 drugs instead of just one.
for optimism , i'll quote this from exel board,lol....
<I guess the successful MTC trial means zilch..based on how people are selling this stock? The reaction seems like there has been a drug trial failure and EXEL is headed for rejection by the FDA. I know this is going to take longer, but this is how most cancer drugs get approved by overal survival criteria. Yes EXEL tried and could not convince the FDA for this unusual path, but this does not take away the fact that it will get approved in the "normal" time-frame and not the "expedited" time frame they were pushing for with Pain as the primary endpoint. It looks like everyone has quickly forgotten that this is a very effective drug with proven Phase III results in MTC. They are going to file for approval on that indication, and any dr who wants to reduce pain in prostate cancer patients has to consider using Cabo once it gets approved (for sure)for MTC.
This is a typical over-reaction due to the fast-trading, type shoot first and ask questions later crowds. After this stock has fallen from high 12 down to 5 , then risen 25% due to positive Cabo results in MTC...it going through the regular trials (OS) rather than the fast track approval for pain as a endpoint trials doesn't change the fact that it WILL have a successful Prostate results and will get approved for this indication. While I think there is a good possibility now that BMS or other big pharma will make an offer while this unfortunate decline in PPS has occurred, I would have bought more shares if I could afford it. Think MEDX just a few years ago. Due to some questionable results the stock was hammered pretty bad, then BMS made and offer with 90% premium. It will be hard for the board and the large shareholders to resist an offer of 12-15 dollars per share at this point. And I think this is likely to happen before the NDA for cabo id filed early next year and before people catch onto the real value of the cabo franchise. >
Hey News, I don't know if I speak for others or not but I wanted to let you know I appreciate your perspective. To put it mildly, this surprised many of us (including you) but each of us pulls the trigger and makes our own decisions. While this one stings a bit, it seems like we were all operating under some reasonable assumptions, and I definitely appreciate your continued perspective and sharing of information. Take care all.
Add me to the "misery loves company" list, folks...sounds like you guys do more day trading than I do (I just buy and hold) but in doing my own research and what I read on these boards, seemed like a good risk. Ouch. Maybe if it hadn't tanked within a day of me buying I wouldn't feel like such a yahoo. But I'll hold on I guess...I got into SLW back when it was single digits, so I did okay on that one (and others)...but I definitely did some "kicking myself" this morning! We'll get through it! Take care all!
That is Funny. Since I am in the same boat...sorta. I didn't tell my wife. Very humorous. However, by far my worst purchase of the year. Live and learn. However, I blame no one but myself and I knew from painful past experience how volatile this industry can be. It has always been and will always be a form of gambling. Sorta like poker or Blackjack.
But I m sophucking embarrassed trying to explain to my significant other that today's 'paper' loss is our biggest yet,but 'it's going to be OK! Sure, we paid twice as much as we could have, but that's what we get being stupid and giving credence to these gawdamn message boards' Pass me that bowl of Red Birds, would ya?
That does not answer my question, what's the course of action for EXEL in order to speed up FDA approval? Do they have enough financing to get them thru the whole process? They can not commercialize and sell product without FDA approval and the current set back does not help the cause.
<<Not a sole knew about their planned changed including the FDA. That was a last minute surprise, not proper conduct. >>
If top management wanted to guard against a leak they might do this.
Board would definitely have to approve before release though.
EXEL wants fast track. They think that the bone scans shows the evidence. The scans were on the web with clear pictures. I saw them. So did a group of doctors (6) in this field that I know. I saw the data as well. These doctors saw the data and feel that they hit a grand slam.
The FDA has recently made many policy changes. More changes this year - than all changes from 1977 to 2010. They have plenty of backing from the big pharms if they need it. They just want to go it alone.
I am upset from what I said in my long post. Not a sole knew about their planned changed including the FDA. That was a last minute surprise, not proper conduct.