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At this point, even if our next data release on the Alz trial is lackluster, it will do little to affect the share price. I don't think it is likely to reveal anything definitive anyway. We are already priced as if it was a failure. We know that we are currently collecting data to drive a successful phase 3. Missling is not worried about the interim price fluctuations and neither should we.
Time is of the essence for Biogen and BP. Missling is negotiating from strength.
The ugly girl in the room just got asked to dance by one of the jocks. Everyone is wondering why, and kicking themselves for not doing it first. She just took off her glasses and is about to let down her hair. Now they all want a piece. What will she do?
Where is the PK data? I'm no scientist but I've done enough DD to know we should have had it already. Is it being used as a negotiating tool? Is it not as good as hoped and they are withholding it to try and soften the blow with some better news? Or do they really not have it? Frustrating!
Having a BP test our drug would not be considered and milestone and is most likely not the reason for the options. That's quite a bit of options. It must be something bigger.
I have a feeling that big news is right around the corner. Possibly a complete buyout for a substantial amount. Given all of the deals that have recently taken place, and taking a look at our tremendous pipeline, one could logically say that we are worth much much more. Misslings contract and all of the stock options that were just awarded abruptly seem to signal something is going to happen very soon.
Biogen just let the world know that they are interested in our little company. Obviously this perked up the ears of big Pharma. If they weren't curious or interested before they definitely are now. Why would biogen let the world know they are interested in our science? That would not be a smart move since it would create competition to buy, partner, license, etc our company and our compounds.
This leads me to believe that a deal is on the horizon. This may be the last part of the partnership or buy you out negotiations. Thoughts?
Biogen has definitely been doing their DD for quite some time. This agreement is probably part of a bigger deal and needs to be disclosed because there is a material agreement. I wouldn't be surprised to see a deal in short order. For large strategic partnership or complete buyout. 2-73 is too valuable to let it get in someone else's hands.
Pretty disappointing that nothing new was revealed. However, his answer to the question at the end was pretty interesting. When asked which direction the company would go in terms of priority, he was unclear.
I don't think he cares. His main priority is to get the drug on the market. And he will choose the fastest route and the path of least resistance. He did mention the lengthy trial of Alzheimer's as compared to another one of these indications. Like many have said before, 2-73 may be best to used as a broad spectrum drug treating a variety of disorders. Others on the scientific advisory board have also stated the same. I forget the wording. I believe Harold Hampel said something to the same effect.
Given the small cash position, this is definitely a smart move. It does not require a partner and can possibly be funded by an outside source. Which obviously means no dilution and no giving away a piece of our valuable pie. Since they were so far along on Alz, there was no reason to change direction. It seems that they are using the data from this adaptive trial as a springboard. They are learning as much as possible about the safety, tolerability and effects of the drug.
I'm going to go out on a limb here, but the Alzheimer's indication might actually be the one that is a licensed out. It is the most costly and the most time-consuming. Any thoughts?
Low hanging, cheap fruit seems to be the name of the game. It may be a good strategy considering how many companies used the same direction to grow.
Should we be expecting a PR telling us there is a new investor presentation? Not sure if the announcement of the webcast is enough to release public information.
If there is no new presentation, it will be so disappointing. MIssling isn't that stupid. Is he?
I'm not expecting anything new but am hopeful for a surprise. I don't believe they announced or released anything at last years conference either. I'm basing this soley on the price action from that day last year.
A new presentation should give us some insight. Didn't IR say that Missling would like to be more transparent?
There is no where to go but up from here. I believe the MJF data provided a definite bottom for us. Missling has the back up financing in place and we are expecting a steady flow of news. These next few months should be very good for us. The bashing articles did not come like usual. Pretty hard to bash MJF though.
Their endorsement said a lot to the street. Maybe our science is real afterall. Shares are going into steadier and stronger hands. We have no debt and our float remains ridiculously low. So far, Missling has definitely been stretching our dollars. Maybe he knows what he have and is reluctant to give it away. Regardless, we just became much more valuable.
Once phase 3 starts for alz, we will be valued as a phase 3 company. Our market cap is comical right now considering all of th blockbuster potential. Well structured phase 2s can easily be turned into pivotals. Having the max tolerated dose established and a year plus worth of safety data saves us so much time with all the other indications.
I am starting to get excited again! After a few months of depression, this is nice.
Come on Missling! It's time to release the Kraken. We've been waiting too long!
No news out of the conference today? I took the abstract to mean there was preclinical validation for Parkinson's. Anyone?
We should be getting news on that. The PRd all other preclinical findings.
Why the change to 36 weeks? That doesn't make any sense. Can anyone explain this? Was the data released in the poster still 31 weeks?
Thanks
We should get a PR if anything good comes out of this conference. Since nothing came out so far, I'm guessing it will be nothing important. It is still early, so something could potentially come out later. Doubt it though. Also, I am looking forward to the new updated corporate presentation which will be out soon.
If the presentation is the same old crap with nothing new, people will be pissed. I know I will.
Corporate overview, to me, says same ole information. I hope I'm wrong. Regardless, we should see a release of a new and updated presentation. If it is the same information, hopefully Missling has learned from the past and is presenting it differently. Maybe highlighting the monotherapy, or shedding light on some phase 3 parameters.
We would like to hear the progress and direction of the company. Considering how we have been spanked, I Hope he is coming for vengeance.
Great post. Thank you for doing that. What is your overall opinion on the preliminary science and the adaptive trial design? It seems that you are somewhat positive. All of this preclinical evidence and the limited data sets we already have must mean something to you. Just curious on where you stand and why. It may help to ease some anxiety.
Also, although the adaptive trial design is somewhat new, do you believe it is sufficient enough to guide a successful phase 3 trial or at least guide us in setting realistic and achievable end points?
Thanks in advance.
Why wouldn't you expect an update when the CEO says an update is coming? Hence the trust issue.
Don't say things if you're not going to do them. A third grader knows that, Missling should too. Money is made and lost on his word, he needs to say what he means and mean what he says.
The street holds him accountable and is listening.
Yes. Where is the 38 week data? And the PK data. He needs to drop a surprise and not telegraph every move. If he withholds it, there would be a real cause for concern. He said he was looking forward to releasing it. He needs to keep his word.
Right now, Missling has a trust and transparency issue. If needs to be resolved. Many dedicated longs have already jumped ship because of it. Everytime we think he is leading is somewhere, we get disappointed. Time to step it up!
Now your getting deep. You are speaking more about test reliability and a persons ability to learn new information. Does the rest truly measure what it intends to measure? Not sure it does. But it's what is available and it is standardized in the industry as of now. So that is our real obstacle and one of the ones we need to overcome. Could the test be better? Of course. In i way I think you are saying the prior knowledge of the patient is gone and they must be treated like a blank slate. Not sure I agree with that.
Also, learning and memory go hand and hand. You need to to able to retain new information. It's part of learning. If you can't remember what you just learned, it doesn't matter. Also, performing simple tasks and following directions is for the most part, pretty cut and dry.
You should take a look at the test. It is simple, short and straightforward. Not much to it. I believe it leaves a lot of room for error and administrator bias. The Adas-cog is more thorough but still quite simple. They both ask the patients to do a few simple tasks or memory recall activities.
The ADL is the one where we saw a drop in score. The assessment is also a little bias and depends on the caregivers information. It is pretty subjective since the patients ability and activities vary from day to day. Also if a caregiver had a frustrating day with the patient, it could skew the score.
http://ab-science.com/ab09004training/pdf/AB-Science-2011.pdf
This is a link to training material for administrators of several different assessments used for Alz. It's informative and gives a quick overview.
We have to remember that it is pooled data. And since there aren't that many patients, all you need is one bad score to bring down the entire data set. Hopefully, one day we could see individualized data sets. That would really give us a good picture as to what is going on. Potential partners and the FDA would definitely be privy to that information and it would be extremely telling. Missling has stated that he wants to be meticulous in guiding the phase 3. This adaptive trial, although very small can give a tremendous amount of meaningful data.
The FDA offers a guideline on adaptive trials which can be found online. That is also informative and can help shed light on the type of trial we are actually running. I have browsed through it and it definitely clarified some things.
I disagree. Safe profile with the ability to easily cross the BBB and a bunch of preclinical validation. What BP would not throw chump change at Anavex to lock up loads of potential and just as important, to keep it away from the competition?
Lots of IP up for grabs here. It's unlikely that we strike out on everything. All you need is one and BP knows this as well as anyone. You have all of these companies resurrecting failed drugs and hammering away at the same old approach. The science is here and much of the preliminary leg work is done. This saves BPs years worth of time and money. It is so worth it. Just waiting for Missling to prove himself and make the right choice n
I'm having a difficult time seeing a partnership that weighs in our favor. With the market Under $100 million a large Pharma can come in and scoop us up easily. If a partnership is inked, what would it look like? Many times in deals like these there is an upfront payment and other payments depending on milestones. Why would a company give us a substantial upfront payment that would equal to a large percentage of our market? The same goes for the milestone payments.
At this point, I feel like a large Pharma could just do a hostile takeover. Even with a poison pill, a big company could still afford to scoop up any additional shares on the cheap. The low market puts us in a precarious position. Thoughts?
I understand things take time and Missling can't give information he doesn't have. But where the hell is the pk data? Long overdue!!
Missling has never been concerned about raising money. It's almost as if he has this quiet confidence that funds will be available when they are ready. The float remains quite low and he still has not tapped LPC. With such wide preclinical success, it's hard to believe we cannot be successful in any one of the potential blockbusters. He could have or should have raised money at several opportune times but chose not too. Why? It's hard to believe that all of these companies are stubborn enough to not give up on old science that has already proven unsuccessful.
This upstream approach that seems to touch so many different cns disorders, with a clean safety profile should be enticing to any company. BP stays ahead by throwing money at promising science and sees what sticks. Our science is potentially ground breaking and Missling's quiet confidence and patience may be disturbing but necessary. I am choosing to believe something big is going on behind the scenes. Hopeful!!
Correct me if I'm wrong but I believe an 8K needs to be filed within two days of the commenced selling. It also needs to detail how much he plans to sell and over what time frame. It also must give some detail as to what the proceeds will be used for. Believe this must be done at each round of selling. These are material events and shareholders need to be notified when they happen.
A lot of shares have been changing hands. Someone has been absorbing them. Hopefully we don't get bought out on the cheap. Missling has a transparency problem. Where is the communication? Today was frustrating ! I do believe there are still BPs that want to refresh their pipeline. Gobbling Anavex would give them numerous possibilities. Who knows. Maybe Missling is negotiating. His resume says he's a deal maker and a finance guy. This is his wheelhouse. So hard to keep confident. Hope is not an investment strategy. Sadly, I feel it's all we have at the moment.
I'm just frustrated about Missling's inexperience. His amateurish moves and lack of forward thinking sometimes makes me think he's stupid enough to do such a thing like sell all the way down here. It's ashame that Anavex is Missling's practice run where first time CEOs can make their mistakes. I hope he is a fast learner.
What do we see happening first? Positive Parkinson's preclinical validation followed by Retts then a phase 3 alzheimers initiation for the encore? If he is able to pull these events off while offering shares to deepen our pockets to run trials then he may just gain street cred again.
There is absolutely no reason why shares need to be offered now. Only a moron would dilute the company at these levels. We have over a years worth of cash. If the shares are offered now, Missling needs to be fired. Plain and simple.
Missling knows they have been the target of several continued attacks. He has also known about the results for quite some time. He could not have expected a sharp rise in sp considering all of the anticipation and high expectations. It is disappointing to have a finance guy who leaves the company with a little over a years worth of cash. The filings were not done until after the poster presentations. Those shares should have been ready for sale a long time ago waiting for the opportunities as they come.
Did he fail in the poster presentation by not highlighting 2-73 more as a monotherapy? Yes. Anyone with a lick of common sense would have presented that poster differently. Some here have speculated that maybe Our science is such a game changer that Missling needs to hold stellar data closer to the vest becuase of the threat we pose. I use to think this as well and always thought of Missling as a great chess player. Now I'm just not sure.
Many of us here have lost way too much money. We have trusted Missling to steer the ship and he has not done a very good job. We have many shots on goal and I believe the science is promising. There are upcoming opportunities for him to right the ship. Let's hope he has learned many valuable lessons.
I wouldn't be so sure of that. I believe recruitment would be quite fast especially since it is such a rare disorder. There are only a handful of organizations and foundations that focus on Rhett's. Therefore information will be concentrated and be easily accessible to parents who are in search of a treatment. Since the treatment options are very limited, once a promising treatment comes to light parents would be eager for an opportunity to participate in the trial. Especially given the safety profile.
IMO. Rhett's is the real prize here and we should be moving on this ASAP. It will put us on the map as a revenue generating company and will open the door for off label use. It also establishes 2-73 as a "real" drug instead of a promising preclinical maybe drug. IMO. Missling did not release the 12 week because the trend was not confirmed at 31 weeks.
At the end of the quarter Missing said he was looking forward to releasing the 38 week data. He said while this knowing the results already. A good CEO knows that investors hang on every word that they choose to use. If he said "looking forward to" knowing that the data is not good, it will be another sign that new leadership is needed.
With the recent filing and the amendments that were made to his contract about his future position with the company lead me to believe something is in the works. Missling has become more and more difficult to read. Whenever we think a plan is forming, it flops and turns out to be nothing but conjecture. Hope this time it's different.
We need leadership now more than ever.
Could this be a potential partner accumulating shares before solidifying a deal? This is the moment Missling needs to prove his worth. Dilution at this level would confirm his lack of CEO experience and vision for the company. Financing should have been done a very long time ago. Hopefully he has a reason for not doing it earlier when the sp was higher. He was not been a good spokesman for the company and has done little to increase transparency let alone shareholder confidence.
In the past, I would always think, "Missling knows what he's doing. He is being very calculated." Unfortunately he has disappointed each time. Now I feel like he's a little boy learning how to play the game of the grown ups despite his great credentials. He needs to restore confidence on the street. His next move will be very telling.
If he does not release the 38 week data, like he said he would, trust would diminish even further. I know PK data takes a long time but this is nuts.