Sorry Doc, but it seems you don't understand this study at all. It is an extended adjuvant study. Meaning that the patients do not currently have detectable breast cancer ( the cancer was removed by surgery). The patients then receive standard adjuvant treatment with Herceptin for 1 year (clinical studies showed no benefit for a second year of Herceptin treatment). This is an extended adjuvant study with neratinib where the drug is given for the second year. The goal of the treatment is to prevent a recurrence of the cancer. it appears that 2nd year treatment with neratinib gives better results than a 2nd year treatment with Herceptin (that's the placebo of this study). In contrast to what you say, the study results are statically significant. Your comments about the stage of the disease in the treatment groups are meaningless since the patients don't have detectable cancer at the start of the study. Finally, prophylactic treatment with imodium greatly reduces the occurrence of grade 3 diarrhea. I suggest you wait for the full ASCO presentation before making conclusions about these results.
excellent analysis doc. I appreciate all information that helps all of us decide which way these stocks are headed. Some good perspectives, and thanks for sharing......
I just read the ASCO abstract and this one won't fly
Data presented is only for survival rates for 2 yrs, that's nothing, what happens at 5 yrs? They have patients enrolled in 2009, they should have data on survival rates after 5 yrs. And even at 2 yrs, not statistically significant. What happened to the original 33%. now is only 2-3%. Who is willing to take 12 extra months of chemotherapy with an incidence rate of 40% to have ongoing diarrhea, more chances of having hearth failure and only to have a 3% improvement survival at 2 yrs? It does not justifies the cost. An there is more the non statistical significant benefits are not for everybody just for early disease (they did not specify what stage), most Breast CA diagnosed are beyond this stage.
Brilliant analysis. Wishing you good luck with this to low 20's. Company has 6 billion dollar market cap, with great CEO, and promising drug. Good luck being short, wish you the best. Bought at 169.7, and now stock is 188. Money in the bank is ok with me.....short or long. Best Wishes..
from 4/15 high 234 steep slide to low 170 on 5/18
now on its way back up again +12 points alone today at 193 now
gotta love the fresh young promising biotech stocks babey
unfortunately, it takes only about $50 million to develop generic Herceptin. why would anyone spend over $1 billion to buy a Herceptin equivalent with severe diarrhea complications? short this one to low 20s
Wishing everyone good luck, shorts or longs. I could be dead wrong, but below is my analysis, and I welcome your thoughts. Knowledgeable and insightful comments are appreciated......
I could be wrong, but I consider this the best value play on the stock market, at the moment. If PBYI is 190+ going into ASCO, uptrends into the 200's afterwards, it will be good. Also, and this is not to be counted on, but there is a small chance of a buyout in the future. Analysts, generally speaking, have included PBYI on their list of top 10-15 biotech companies for possible Biotech acquisitions going forward.
My take is this: I place Clinical Research Associates at pharma companies nationwide. I analyze resumes for a living. This CEO has a world class resume and accomplishments, it is one of the highest qualified resumes I have ever seen. He did it previously with another Biotech company, and it was acquired. Drug has promise, and should be validated again at ASCO and beyond. I think it could be 190+ going into ASCO....not an unrealistic scenario considering it is 181 now. I expect a slight uptrend to continue into ASCO conference on June 1st. More details about phase 111 and their top drug neratinib should be released then.
The CEO's leadership should shine through in the longrun, as he has hired some of the most talent individuals in the Biotech field to navigate PBYI.
CEO compared the Hazard ratio (.5) to the leading cancer drug on market Herceptin, from Roach, with a (.7) Hazard ratio. Apparently the .5 ratio is acceptable compared to the .7. Additional information on the phase 111 trials will probably be released and explained then. The trials are not that easy to interpret. I am sure the CEO, who has world-class, impeccable qualifications, will amplify upon results at ASCO.
WOW! Can someone really be this ignorant? You are likely doing too much of what your handle suggests and it's killing some brain cells.
the hope is gone, analyst try to calm your down, be careful here. Unless something up for good. it will be lots of sell from institution and insiders. I could be wrong, but i can't sleep well now.
It is not that difficult to understand. The drug is very approvable. Secondary endpoints, subset analyses all point to clinical benefit and the side effect is very manageable based on other data. Don't forget that these early BC patients have all been treated with Herceptin for a year already so the survival is gonna to good. The question will be the market uptake. The projection was $3.5 billion which would translate into at least $17 billion take over price. If they can do half for $1.7 billion, it will still demand $8-9 billion market cap. That's why the issue will have support.
I am slowly coming to the conclusion that most trades we see during the day are fake. Just computers of member firms lobbing stock back and forth making it appear like there is more going on than there really is. Not just for PBYI but most stocks, unless there is a compelling event attracting interest
Especially with weekly options. That has really killed volatility intraday. All the big moves are between trading days in the form of gaps.
Odd how much support it had though. I don't understand the long's side of the story now. But apparently there are still plenty of believers, otherwise this would already be below 100.
With the weekend beckoning, look for the funds to further exit their holdings to protect their profits. Large gains on equities like this can be eviscerated in seconds as news is disseminated and commented on over the course of a weekend. I suspect a steady decline running up to the close – where it ends up is anybody’s guess – but I fear the worst is yet to come.
This stock was priced for absolute perfection while the street was looking for a much more robust efficacy profile. The selling pressures today will be ugly.