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I'm trying to stick with the theme here. Say all you can, except the obvious, then go silent.
Great, hope you do well in this stock. Time will tell who gets the gold star. My shares should be enough for a comfortable retirement if it pans out. Let's hear the plan for stepping on the gas with this, I'm not getting younger.
What if someone tipped off AF that the trial endpoints were changing, in December as Missling stated. Share price started to decline at that time. AF used the January 18th date as a defense to his timeline of knowledge. The short attack was already underway. The hit piece would be used to cover, or make more money on the way down. Was there a leak? When was the CRO updated? When was clinicaltrials.org updated? When was the website updated? These are not really significant in the grand scheme of things, but when timed right? It's the Cabal. Seriously, what was the timing of all of this... Or, what if AF was used as a pawn. Someone else gained knowledge in December and began shorting. They tipped off AF, knowing he would jump on the opportunity, and be provided protection under anonymity. Book sales will start soon, or maybe before end of year, or sometime.
The title and subject of the book may change without disclosure. The book may be cancelled at any time without notice.
Add to this a shaky market.
Because investor confidence had already waned on missed trial dates and a little push clouding the waters tipped the remainder. The losses prior to release of trial results was enough to put some investors into a "stop loss" mode, not willing to accept more risk and potentially more loss. Anavex is developing a track record of providing information then going silent, missing targets with no explaination, then issuing options for meeting milestones. Additionally, trial readouts are often not complete or clouded due to, yet again, lack of communication. Finally, Anavex tends to challenge the use of endpoints. This is clever in part, "precision medicine", but has also backfired in areas where they were not completely familiar with the science. The odds are against success, and often, if it walks like a duck, quacks like a duck, and looks like a duck, it's a duck.
Good post Doc. I agree with your thoughts on the survey interval. With significant variation, more samples would be better for statistical analysis.
I thinkng that is already happening, and that is where Missling shines. Missling understands the value of what we have, present and future. He also knows what it takes to cross the finish line. He has done a great job minimizing costs associated with clinical trials and drug development. Securing grants for research has helped this company stay alive. We are in the final stretch and have many loose ends to tie up.
BP will not pay fair value. A BO is instant gratification at a significant cost, and all BP investors will reap thier small share of the benefit.
Pound after pound eventually leaves nothing left. It amazes me sometimes the amount of information this message board tries to reveal by sleuthing. While it might be a fun activity, it seems a little childish for Anavex to make it that way. They announce investor conferences but don't provide meaningful updates on trials? I remember years ago the message board didn't want Missling to release too much information because it could be used against him. The point of that was missed. Brief, succinct status updates are appropriate about things that matter. Where are we at with enrollment of EXCELLENCE or the AD trial? Have the endpoints changed for EXCELLENCE, we just recieved information that RSBQ was not appropriate in the last trial?
To add to this, Analyst coverage is a joke, either way. Who do they work for and what are thier motivations? There is no good story to build on yet.
BP will ____ all the investors here. They may offer a dummy role for top employees here, but they don't need anything from Anavex other than thier IP. Do you think they will value any of this fairly? Why is our sharepoint so low? Because we are a little fish in a sea of sharks.
When revenue starts coming in either there will be fat dividends or the company will be valued properly. I think Blackrock knows what's going on here. Alot of the shares here are still owned by sharks, making money wave after wave, on silence, fear, doubt, and hype. The volume illustrates this nearly every day.
What good is a gold statue if it's painted grey? Right now we are at the mercy of the market. If the regulatory agencies approve we are at the mercy of the medical community, until patients and caregivers can speak. We live in a social society and even BP can't stop that.
Hope they are extending the open label for EXCELLENCE. 48 weeks may not get participants to readout.
This is a 12-week placebo-controlled study of ANAVEX2-73 oral solution for the treatment of patients with RTT 5-17 years of age. A voluntary option will be offered for all patients who meet the exposure criteria for ANAVEX2-73 to continue a 48-week open label extension.
The penetration rate seems very conservative in thier calculations. Maybe because they expect an alzheimers treatment to have many side effects, minimal therapeutic benefit, difficult to maintain, and an aged population. A pill that is priced properly, is easy to administer, very minimal side effects, and provides noticeable therapeutic benefit will spread like wildfire. What do patients have to lose? AND, although it would not be approved by the FDA, could likely be used in conjunction with other therapies. Pricing will matter, and in the article referenced they used an annual cost of $30,000.
This may not be a good position for our Excellence trial. If Anavex changed those endpoints for Excellence, they should update now. Saying that endpoint is bad invalidates the endpoint in the much larger and significant trial for children.
Primary Outcome Measures :
RSBQ [ Time Frame: 12 weeks ]
Change from baseline to End of Treatment (EOT) in the Rett Syndrome Behaviour Questionnaire (RSBQ) Total score
It took 14 days for them to post that information after Acadia posted topline results. Give them time to analyze the results and get feedback from Anavex before posting something (something a credible organization would do versus a hack like Adam Feuerstein).
The evidence is anecdotal at this point. Why add risk? Complete the trial as planned. Offer an extension, like previous trials. Why was the trial designed the way it is if less is adequate?
Ah, so all this loss is from shallow, uninformed investors.
Who is buying then?
So, lesson learned. Trial design and designation matter to investors. Why, because that is what investor money is spent on. No spin for the win when you disclose going in.
You should read the article though before commenting.
At a mere market penetration of 1/4 of the projected 6.8 million Americans by 2025 at a mere $12k per year, assuming other indications follow shortly, is $20 billion in annual revenue in just the US. In terms of share price, that is roughly $204/sh with no future projection. Add whatever multiple you want, adjust for other markets, and add other large scale targets like epilepsy, FDA approval will launch this into crazy money. Consider what dividends could possibly look like. The best thing is if patients benefit, even at an ungreedy cost, Anavex will gain support.
This does not need to dilute much further. Early investors have been beaten up, and the wolves will want thier share. Trials need to complete, FDA needs to make a decision and the games will end. We'll see who gets a gold star then, maybe literally.
And they didn't know that when they gave a $27 price target? Oh, so the original endpoints were approvable. What a joke. Wonder if they shorted Anavex? You know, since all analysts are honest.
Like this guy? He needs assistance, and he needs to realize that. He is running the company as both CEO and Director.
Dr. Missling has over 20 years of healthcare industry experience within large pharmaceutical companies, the biotech industry and investment banking. He has been an investment banker in the healthcare practice at Deutsche Bank, serving pharmaceutical, biotech, and diagnostic companies, and most recently was head of healthcare investment banking at Brimberg & Co. in New York. At Aventis (now Sanofi), Dr. Missling worked as head of financial planning on all aspects of financial strategy and M&A. He was the Chief Financial Officer of Curis (NASDAQ: CRIS) and ImmunoGen (NASDAQ: IMGN) where during his tenure shareholder value increased significantly. Dr. Missling has an MS and PhD from the University of Munich in Chemistry and an MBA from Northwestern University Kellogg School of Management.
So you're saying it's worth something...
I guess it depends on where you get your coffee.
Feels like another short attack brewing to tip those that are on the line and by association "validate" AF's argument for the time being.
Just out: Anavex CEO Says 'Inaccurate Impression' Clouded Rett Drug's Promise
A third-party website called ClinicalTrials.gov shows Anavex changed the goal posts on its test — and the actual phase of the study — just two weeks ago. But Missling says the changes were implemented in December. The website was updated late.
"The administrative updates on the website were not made on a timely basis by the CRO (clinical research organization), leaving the inaccurate impression of a late change, which was actually not the case," Missling told Investor's Business Daily.
Anavex CEO Says 'Inaccurate Impression' Clouded Rett Drug's Promise
Timing of clinicaltrials.gov updates has already been a discussion in earlier trials of A2-73. Investors that know little about the clinical trial process were taken advantage of over technicalities. The legal posturing needs to be taken into consideration and the legal system needs to pierce the claim to ignorance.
It appears that Adam prepared his news response prior to release of trial results. Did he perform his due diligence to confirm changes with Anavex before posting? Did he inform other investors that he was going to release this information prior to release? The stock price has fallen significantly since January 18th. The overall tone of Adam's news release was that Anavex manipulated the trial data, regardless of the use of words like may or likely. That is a serious allegation. Additionally, Adam used a news feed to post these allegations during a news release cycle of Anavex.
If someone were to attend an event where people are gathering and because there is a lighter on the floor, they plainly say "there may be a", then yell "fire!", and this announcement results in people being injured, who is at fault? The other piece of this is that the person that shouted out saw the lighter on the floor a week ago, before gathering, so they told thier friends to attend and hang out, because it is likely people will loose valuables as they are rushing out the exits. They didn't bother to say anything prior to the gathering.
What was the intent of Adam's news release?
What was the intent of Anavex's news release?
Thank you!
Anavex did this and the wolves are taking advantage.
I don't get how these were last minute changes. The data was gathered per a protocol; you can't change that at the end, the data was already gathered. There is NO way Anavex does not have the data per original trial design if they followed the original protocol, otherwise it was changed at the beginning of the trial. Unless the principal investigator did not understand the assignment and they tried to fix it afterward. Again, we are all left speculating because Anavex won't update investors.
Yeeeaaahhh, keep telling yourself that. In the end you're right, FDA's decision is what matters. Whether or not this is a good investment in the meantime is another story. This could have been avoided.
Right? This is frustrating. In the end data will play out. FDA will make decision on a sound data set, regardless of what AF says. Yet another round of being beaten up over nothing.
The key is "as soon as possible", not after the trial is complete and results using new endpoints announced. If they changed on January 18th, why not explain then? Better yet, if they planned on new endpoints based on FDA guidance at the beginning of the trial, update trial design then and announce why you are doing it. These are simple things... if they can't handle the simple things, what else is going on?
What you are suggesting is that data was collected under the original trial design. The post I responded to suggested that there is not sufficient data to report on the original trial design. This is the perception piece... when the design was changed it should have been changed at that time, with a press release explaining the changes. Instead, we now have data based on a trial design change, at the end of the trial. Whether the FDA recommended or not, the perception is that the trial design was changed after the fact. When did the actual trial design change, and where is the communication?
The problem I see in this case is that they collected data the for a method that was not defined in the trial design. If they intended to conduct the trial in this manner, they should have updated the trial information before the fact. Data is data, but image is perception. This is the problem every turn with Anavex. There seems to never be a straight answer up front, so regardless of how good the data may be, there is always the perception that the company is not being totally forthcoming. Get someone in there to pull thier head out of you know where so the alzheimers trial isn't screwed up too.
So... the stock price falls significantly prior to release of data. Endpoints were revised and AF has a hit piece waiting. Did AF tell his buddies that it doesn't matter what AVXL releases, they changed enpoints so I am going to release a hit piece and tell everyone that the data is irrelevant, regardless if it is good or bad. Short, short, short. The real question is, did Anavex change endpoints after data was in hand, and if so why? What did the original endpoint reveal?
There appear to be additional enpoints...
Is there a way to post a snip of the trial changes?
This doesn't appear to include earnings from alzheimers... another trial?
George, the losses seem much greater in AVXL, do you agree?
Is the trial complete? Is someone reviewing the data?
It will be interesting to see if any of it is dilution.
$152 million cash on hand 9-30-2021.
"A study published by the Tufts Center for the Study of Drug Development published in the Journal of Health Economics in May 2019, gave an estimated cost of $2.6 billion. That study broke down the number to include approximate average out-of-pocket costs of $1.4 billion and time costs of $1.2 billion."
https://www.policymed.com/2014/12/a-tough-road-cost-to-develop-one-new-drug-is-26-billion-approval-rate-for-drugs-entering-clinical-de.html
34 million shares remaining, including blank check, or 44% of shares outstanding.
If approved, how much are production, distribution, and marketing costs? What are the costs to generate revenue?