We can't keep burning cash for drugs that are way out in the future. Focus on the drugs that have a great chance of success that are in the pipeline. We don't have the capital to try and discover new drugs every day, move 7 drugs through the pipeline and deal with Eisai.
Bashers have been screaming cash burn and bad management. Now we get a guy in there that cuts costs, focuses on the drugs that will bring value to shareholders sooner and reduces the need to dilute in the near future. Buying us more time. I would have done this years ago, and my first lay off would have been Craig Audet that has done nothing for us in any way shape or form. In charge of global regulatory affairs and can't get a complete package to any of the other countries, refuses to hold the marketing partners to any standards. The guy is a total waste and so are most of the BODs.
We get a new CEO, shortly after that we finally get a new CFO. And within the first few weeks, they put in a strategy and a cost savings plan and execute it immediately.
Isn't this what we all were asking for the last 2 years? Someone to have a plan and execute on the plan?
17 red thumbs from people who what? Wanted to keep burning valuable working capital with no end in sight? Having to dilute again and again?
From Fortune Magazine.
Layoffs are often a sign of failure by top executives to properly manage a business and forecast needs — and failure of board members to ensure that the right management is in place.
The previous management refused to address or fix their mistakes so we brought in a new CEO and CFO who took care of it for them.
The company is a goner either way and you grasping for straws is not going to change it. Just a case of trying to read something into the tea leaves. Even management did not put up a fight, or say here are the results, we will look into the data and try and understand what happened. Nope they just came out and said, we are stopping the study...
You made the claim with no link, I searched all of the articles this person has written and that article did not show up in a Google search. So as far as I can see you have nothing to back your claim.
Its OK Dan, Denial is the first of the five stages, denial, anger, bargaining, depression and acceptance are a part of the framework that makes up our learning to live with a loss.
Soon you will get #$%$ and angry and so will everyone else, then the real damage will happen, the lawsuits will start to fly.
Nope, the patent was granted giving them patent protection. They will prove the patent and we will find out who is playing games soon enough.
The company at this point is dead either way. If the data is wrong then they will get sued for coming out and discontinuing the study without doing any investigation. If the IDMC findings are true then they have nothing to move forward with.
A thought from my perspective is, look how quick management was to accept the findings and make their decision and to come right out and stop the trials without any fight or investigation. It is as though they knew it was going to happen and so they put up no fight. I don't think they were blind sided by the results. I think the disappointment is they will all have to go find new jobs and this cash cow will no longer be milked...
He did not do this alone. He waited for the new CFO to be put in place as well and within 30 days they made a plan and executed that plan... I for one view this as a positive, yes, 2 years late but it is a start. If this new CEO and CFO can make this hard decision, I believe they are the ones that can play hard ball with Eisai. Jack was a push over and a Liberal at that so he could not and would not make the hard decisions..
belive they can manage with the current cash on hand and projected to come in, through the end of all the Phase 2 study results. So you either belive them or you don't, and if you don't, why do you think they are not being honest? What historical evidence do you have that they can not be trusted? They have major stock options at these prices, does them no good to tank the stock down from here.
If the stock gets way ahead of its self does that create an opportunity to raise capital, yes, however I would argue that both Kevin and Amit know this company has a credibility issue with investors and Wall Street so they will try as hard as they can to hit dead lines and to do as they has guided, to build confidence in the new management.
For the record I am in the same boat, I was long the stock and was looking for great things. This is more then a disappointment for me as well, I am going through the anger stage as well. How could the results half way be so far off of the Phase II study. I was one that thought we would only get a go to completion, I was not in the camp of Halt for efficacy or halt for futility. And to see the drug arm performed worse then the Placebo is just crazy..
Enough with the personal attacks. This is a stock board, a place to debate the merits of ARNA as an investment. GROW UP
Wrong, been on the market for 3 years and no real issues other then those seen in small percentages during clinical studies.
You did not say blockbuster, clearly Belviq is not a block buster. You said "don't sell" and Belviq has sold and is selling. Not for lack of demand, if it was over the counter we would be selling millions a quarter. Doctors are not writing scripts. They are stuck in the diet and exercise talking points. Some would rather give surgery referrals then script a 75 dollar drug... Criminal in my opinion. But soon they will have no excuse.
The big question is after the CVOT will we be able to get the Schedule moved from a 4 to a 5. I think the unknown was one of the reasons for the Schedule 4 designation. After the 5 year study we will know if it has abuse issues or other issues keeping it at the 4 designation..
I don't think that will change any plans, sales are revenue and that is the primary goal for all for profit organizations.
IDMC made a recommendation, not an order, not a decision. A recommendation based on their findings and stated with that recommendation that if unless their was a mistake or unless other data can be found that recommendation stands...
Management could have released a PR stating the iDMC is recommending a halt for futility but we will investigate their decision and take the next 2 weeks to determine our path forward. That would have been within legal safe harbor, and left the door open to challenge the data and the decision. Giving up and throwing in the towel tells Me they were not surprised. Oh they say they are surprised because they have been milking this cow for years and saying anything else would mean they were pushing a fraud.
Dan, what you did with my-gale was awesome and that was a great place to get additional information without all of the personal attacks. So thank you for that. If i may add, next time maybe you should have invited scientist from both sides of the argument. Because all of the Dr.'s you brought on were cheerleaders, smart cheerleaders but none the less they were all bullish and had all but guaranteed that a halt for futility was off the table.
Belviq selling over 500,000 scripts per year so clearly it is selling... and a lot of folks are taking it..
Thanks for the confirmation, I found nothing as well. Clock is ticking and when the CVOT is finally done no more reasons to avoid scripting the drug. Hopefully we have a Pfizer or Lilly at the helm of Belviq at that point... Eisai could not sell water to a dehydrated person in the desert.
Galena Biopharma (GALE) Receives IDMC Recommendation to Cease NeuVax Phase 3 Early Due to Futility
IT was a recommendation not an order or a requirement. They could keep the trial going and investigate the findings. They could halt the study and investigate the findings. But they came out and stopped the study 2 days after they received the recommendation. They needed to make exit plans before they announced the halt.
Seriously? Well you keep wondering, the drug has been on the market for 3 years and no real issues reported. Hypersensitivity is not a big life and death issue. Belviq will not be taken off of the market. Chantix was given a black box warning and still stays on the market and is scripted every day. Clearly you do not understand how things work in the real world.
First and foremost I am long, or I should say was long on Neuvax. never GALE management.
These word games are just that games. The IDMC did exactly what I said, they basically gave their recommendation to Halt for futility unless someone can prove to them the data was faulty. It does not mean they see something or that they think the data was screwed up... They are saying this is our decision based on the data we had. Now GALE management is going to raise money spending resources looking into every aspect of the failure.
If Neuvax does not work and does in fact create issues those combo trials will need to be stopped. Then we end up with a pipeline that is years out. They want to milk this cash cow. I sure hope this bounces back up. I will offload the shares...