I am not going to give you any credit by responding to an idiot like you!
U need lot of help!
If I speak the truth it is arrogance! You want me to agree with you like half the people here. Why do I even post here for a bunch of ungrateful people like you. If I did not post the recent Ahn interview, you would not hv known about it. Then people like you want to hear what you want to hear.
Every investment case has two sides to it. It will make you a better investor when you understand the downside! I know this is Greek to most Koolaid crowd here.
Q: How is the formal launch of Abstral proceeding?
A: We launched Abstral, the first and only sublingual fentanyl, on October 1 and are very pleased with patients who prefer the simple, reliable dosing versus other mechanical products available on the market.
Payors have also been supportive, and we have over 300 million lives covered from a managed care perspective. We have reimbursement, manufacturing and distribution all intact—and Abstral is available in specialty pharmacies and outlets nationwide.
We are focused on trying to achieve 10 percent to 15 percent of the market in three years, which we are on track to hit. The product creates value and builds a commercial call point for the future since the same solid tumor treating physicians for breakthrough cancer pain meds would also use NeuVax.
Q: What is your current cash position?
A: We had $55 million at the end of September. We are looking to continue building and strengthening the depth and breadth of our development and commercial product pipeline to build value for patients and investors.
Q: What are the major upcoming milestones we should be on the lookout for?
A: Our key milestones are complete enrollment for the NeuVax trials, meet or exceed our target of $8 million to $12 million in Abstral sales, become a cash flow positive business, and obtain an ex-U.S. regional partnership for NeuVax beyond our arrangement with Teva in Israel. We are also hoping to start the Phase 2a trial for our Folate Binding Protein-E39 vaccine.
We have finished the Phase 1 and will start the Phase 2 in ovarian and endometrial cancers.
Q: What kind of partnerships are you considering?
A: We are pursuing global partnerships where Galena would maintain rights in North America. After we have interim results, we believe will be better positioned for partnerships and are working towards achieving this goal next year.
Provider ID: 52af072001e4049452af072001e40495
-0- Dec/16/2013 13:58 GMT
. Around 55 percent of patients are node positive and 25 percent of those have a risk for recurrence within 3 years. Our focus is to move from these clinical prognostic factors to a targeted HER2 based treatment. The stakes are high as these patients only have one shot at durable remission. Once the disease is metastatic, they can be retreated but it very difficult to achieve another complete remission.
Q: When will the Phase 2b trial in combination with Herceptin complete enrollment?
A: Preclinical work suggested that NeuVax and Herceptin
(trastuzumab) may work better in combination due to their complimentary mechanisms of action. Basically, Herceptin can increase antigen presentation by tumor cells by promoting receptor internalization and subsequent proteosomal degradation of the HER2 protein. In turn, NeuVax, which is a CD8+ T cell eliciting immunotherapy, efficiently recognizes and lyses trastuzumab-treated HER2/neu-expressing tumor cell lines.
Results from a Phase 2a combination study were reported at ASCO and in 62 patients, at the two-year mark there was a 12.5 percent recurrence rate in the Herceptin only arm (n=32
patients) and zero recurrences in the combination arm (n=30 patients)—and the data continues to be encouraging. In our clinical collaboration with Roche/Genentech and the Henry M.
Jackson Foundation, the Phase 2b trial will randomize both node positive and node negative patients. We are currently enrolling at 11 sites in the U.S. and target completing enrollment by the end of 2014.
Q: How would NeuVax be manufactured? Are all CMC issues resolved?
A: NeuVax is an off the shelf synthetic peptide which does not require any expensive or complicated autologous procedures. The well-validated HER2 oncoprotein target is remarkably well- conserved, even between species. It consists of a 1255 amino acid sequence. NeuVax represents the immunodominant extracellular peptide from HER2 domain, which is given with GM- CSF (granulocyte macrophage colony stimulating factor) as an adjuvant via simple intradermal injection.
Women with strong immune reactions have a measurable circumference of redness known as delayed type hypersensitivity, which appears to correlate with efficacy. We also monitor levels of circulating tumor cells in both the adjuvant and metastatic setting as a measure of potential recurrence risk.
Also, we are developing a companion diagnostic with Leica Biosystems, which already has one of three commercially approved
HER2 tests. Leica will commercialize the companion test and we will co-apply for FDA approval. We are ready to manufacture the drug.
I will break it down and try to post it for the non-believers and the ignorant here!
Q&A: Galena’s Mark Ahn On Abstral Launch, NeuVax Trials
2013-12-16 13:58:56.918 GMT
Mark J. Ahn, President, CEO, and Director of Galena Biopharma, said the company is on track to capture part of the breakthrough cancer pain market with the launch of Abstral. In an interview with Bloomberg’s Elizabeth Krutoholow, he explained how the relationships the sales force forges with oncologists will came in handy when the company commercializes NeuVax, its Phase III candidate for breast cancer. Galena will report an interim analysis from this study that should wrap up enrollment in the first half of 2014.
Q: When will the PRESENT Phase 3 trial complete enrollment? When is an interim analysis likely?
A: The primary endpoint of this study is to prevent recurrence in high risk, node positive breast cancer patients. We have over
130 sites accruing in 15 countries. We plan to wrap up in the first half of next year. The interim analysis is event driven and will evaluate safety and futility. It will occur when there are 70 events, and the analysis will be done by an independent data safety monitoring board. The final endpoint is disease free survival at three years where we will look for a separation between the treatment and placebo arms. The trial is being conducted under a special protocol assessment with the FDA.
The current standard of care for newly diagnosed patients is surgery, followed by adjuvant chemotherapy and then radiation to destroy remaining cancer cells. The PRESENT trial looks at high risk adjuvant breast cancer patients who are node positive and have low or intermediate HER2 expression (IHC 1+ and 2+). These are not eligible for treatment with Herceptin or other HER2 targeted agents like Perjeta and Kadcyla which target HER2 over- expressors (IHC 3+).
There is a large portion of patients who have been treated with the standard of care and are in this so-called “watch and wait”
period. Around 55 percent of patients are node positive and 25 percent of those
" I would think"
I have never seen any evidence in the past that you are capable of thinking! You seem to know more than the guy who is running the company. A person's stupidity should have limits but in your case......
Coming from you Stockwatcher I love that!
Do you know the difference between a stock and a rock?
Except crucifying the people who disagree with you and posting info in the GALE website for the last couple of years, have you done anything useful lately?
Do you know what makes markets? Buyers and sellers.
I will take it as a compliment. You two must have given thumbs up for the Coheninvestment group post today!
The truth hurts or you do not understand what I post. Get back to your massage job!
It looks like they are twisting the story. Georgens only mentioned abt the offer for the family shares but nothing about the cash offer for the public shares. Obviously the board went along with it. I think there will be law suits.
What is your point? why should I lie? I told you where to find the source. Most investment professionals have Bloomberg terminals. Try your broker or the nearest public library. I even volunteered to send the article.
I have nothing to prove to you!
Get hold of a Bloomberg terminal
Then type GALE equity go
Then type CN for company news.
It will be the 3rd or 4th item
It was an interview on 12/16
Thank you. It is conflicting. Did you check in Bloomberg web page? I have a terminal. I do not think I can cut and paste here. I will try.
Honestly Roger, I do not think a poster (an article not a post) makes any difference in the price in the long run. In the short term may be.
Where were the bashers when it climbed from $2-4.70? Non one complained.
Tagareth, you are a very smart man if you sold at $4.70. things you projected are in the price. You think the investors do not know about P3 enrollment. Abstral sales and MORE are in the price. Interim results is a 2015 event if the enrollment happened in the first half of 2014.
GALE was at $2.14 on Nov 1st. It can easily get there.
Ahn gave an interview to Bloomberg a few days ago. I posted a summary. 10-15% number and the datelines for the NuuVax trial came from that. Pls see whether you can get hold of it. It was a question/answer session with a Bloomberg reporter. He did not give a date for the interim results but said after 70 events.
just show me how the stock can get to $6 on Astral?
Look at the CEO's interview with Bloomberg few days ago.
He targest 10-15% of the market in 3 YEARS. That works out to $400mmx15%=60mm. apply 4x5 sales (that is what pharmas trading at) to this and one can come up with $300mm. That is in 3 YEARS! GALE has a MC of $400mm already.
NeuVax enrollment will be completed first half of 2014 (not end 2013). Interim will be after 70 events. You will be lucky if you get something in 2014.
I think the slow march to $2.50 has started. GALE has never been able to hold onto rapid gains in the past and I do not think history will be changed this time.
If you ask Stockwatcher he will tell you that this stock will be headed to the moon! You know the quality of the some of the longs here the way they reacted to Coheninvestorgroup posting today which is a bogus!