And Novartis just made inquiries about Tivantinib after a cc earlier this week so the race is on. We need to really take the pipeline to the next level, Puma; so put call a meeting this weekend and start acquiring one or two of those other aggressive pipelines out there and take us to $400.00/share next year, please!
The closest thing to a cure to date. Second best combination therapy is Neratinib plus Trastuzumab. Puma could dominate the cancer market but they need to beat Janssen and Daichi Sankyo to the tinib punch bowl.
This stock has been way overpriced for months. Total manipulation by Hedge Funds.
Compare this to Mannkind. New outstanding therapy for diabetics approved and partnered with a world class partner in Diabetes care in a market that is growing by billions per year, soon to be a $58B/year market and the stock sits at less than $7/share. This company has no approved drug and has now just revealed that their only candidate is mediocre at best. and it's still above $200/share. This is manipulation at its best.
Sentiment: Strong Sell
Knowing that the effectiveness of treatment is reduced once cancer has metastasized — that is, spread to other regions of the body — researchers are now testing creative ways to prevent such recurrences. One, a specially designed vaccine called NeuVax, is in the final stage of multinational clinical tests under the direction of Dr. Elizabeth A. Mittendorf, a surgical oncologist at M.D. Anderson.
The vaccine is made from a peptide, a small piece of a cancer protein, that is combined with an immune stimulant. Early results suggest that the vaccine can reduce the risk of recurrence by 50 percent among breast cancer patients whose tumors produce low levels of the protein HER2, a marker for more aggressive breast cancer.
Without the vaccine, such patients have a 20 percent chance of a recurrence, Dr. Mittendorf said. Rather than waiting to see if a patient’s cancer comes back, the vaccine is given at the time of initial treatment, when few if any cancer cells are present, she explained.
PUMAS diversify befroe you lose out…..imo
Sentiment: Strong Buy
Good luck with your short position, bwillis1701, but don't forget the NSABP FB-7 readout could print the 2nd week of December (based on recent Street reporting of Principal Investigator's comments). If that data is strong and shows Imodium prophylaxis dramatically lower than non-prohy 30+% historical toxicity (like the recent NSCLC readout that showed neratinib G3 diarrahea decreasing to 8%), the stock could get marked up quickly. The other big, obvious open item is the ExteNET safety and trial details. Since the CEO said in an interview with UBS's Roden a few weeks back he's not losing any sleep over ExteNET safety detail, which is supposed to be unveiled in June at ASCO, unsure what "in question" means. Keep in mind the CEO would be putting his $1+ billion personal equity position in Puma on the line, not to mention his personal freedom, should he be knowingly "misreporting data" as you note. There is no logical reason to believe that is the case as this is a near $7B company, not a $50M biotechnology flier. Do you know Alan Auerbach's history with Cougar? I think you're reading it all wrong. Regardless, talk of a $50 or $10 stock is silly. Neratinib has been in about 30 trials and thousands of patients. In my analysis, sum of reasonably handicapped parts keeps us dramatically higher than that even if a some things go wrong. NDA will filed in early 2015 and neratinib will be approved for it's first indication as planned. That is my expectation. We'll likely see soon enough which thesis is accurate.
google :Dept of Defense, NYTimes, and MD Anderson Ctr , rated #2 in world by Consumer Rports., google each of these and Neuvax by GALE...
Sentiment: Strong Buy
He is likely referring to the p value. And is expecting neratinib to show superiority to Herceptin and becomes the new standard care. That is not gonna happen and no one is expecting that all.
1) Neratinib NDA submission for extended adjuvant therapy in met breast cancer (HER2 positive) will in 1st half next year. At this stage not sure whether it will be Q1 or Q2. Puma need to compile all data on Neratinib trials so far (safety). There are about 30 trials so collecting information on all data will take some time.
2) The phase 2 data released yesterday is positive. Phase 2b demonstrated non inferiority to Herceptin and potentially superior to Tykerb on both PFS and brain mets, making a case for best in class for HER2 positive, first line and met breast cancer patients. There are 3-4 options that Puma can design a registranable phase 3 trial for sNDA submission, and potentially adds substantially more value to the company. It makes it to be an even more attractive take over candidate.
Share prices should reflect these positive development once all these fud and fear settle.