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Access to Noble's 53-page initiation report on AVXL is available via a link contained in this press release: https://www.prnewswire.com/news-releases/noble-capital-markets-initiates-research-coverage-on-anavex-life-sciences-corp-avxl-300403268.html. While it may be frustrating not to get a return call, understand that it's because they can't say anything beyond what is in the published research report.
The biotech industry is littered with small biotech companies that failed due to poor management, not bad science.
To me, the issue is not Dr. F having the right connections at the FDA. Rather, what I'm wondering is, Why didn't the IND didn't sail through on the first go around? First, they must have had the usual pre-IND meeting, the goal of which is to receive confirmation from FDA that the drug development plan and future clinical trials are acceptable to the agency. Also, with Dr. F's 24 years of experience with FDA regulatory filings, you'd think he'd get the filing right the first time. We don't know what we don't know, but it is a head scratcher.
I think Lane misses the point. While it is fair to say all anybody has to do is do better than the standard of care (a pretty low bar since there's basically nothing that really works), nobody has jumped over that low bar thus far, including cash-rich pharma companies that have deep science, thousands of researchers and huge development programs. Maybe they're all stupid and Anavex is smart. Maybe they all have blinders on and suffer from Not Invented Here Syndrome and therefore have overlooked 40 years of published literature on Sigma-1. I don't believe that but I can't be 100% sure. So that in a nutshell is the bet.
Missling touts improvements in MMSE scores in the AD trial but... In an article titled A Clinical Perspective of Data From the Consortium to Establish a Registry for Alzheimer's Disease (Arch Neurol. 1999;56(7):857-862. doi:10.1001/archneur.56.7.857), the following is stated about MMSE scores in the Conclusion:
Although the Mini-Mental State Examination is a useful screening instrument to assess level of cognitive function, it has limited value in measuring the progression of Alzheimer disease in individual patients for periods less than 3 years because of a large measurement error and substantial variation in change in annual score.
The Conclusion further states:
Although the MMSE is useful as a screening tool and as a marker of cognitive change in patient groups, to our knowledge, its utility as a measure of change in individual patients has not been determined. During follow-up of an individual patient, the standard required for a test to be a useful measure of progression is different than in the analysis of group data. Although score changes for patients can be reliable and meaningful when averaged over the entire group, the same magnitude of change may not be reliable or interpretable when observed in one patient measured on 2 occasions. This study examines the long-term variability of periodic MMSE assessments to determine the utility of the MMSE to follow progression and help guide the clinical management of individual patients with probable AD.
If you really want to try to hold Missling accountable, write detailed letters to every one of the company's directors: http://anavex.com/about-us/management_directors/. If 100+ shareholders send letters to every director, perhaps the directors will take notice and start asking management the hard questions we all have. Letters addressed to directors sent to a company's headquarters must be forwarded. Address here: http://anavex.com/contact/.
Slide 18 tells me there are still a great many questions to be answered before trials can move forward. The stated goal has been to obtain predictive information so that positive trial results are assured. Clearly they're nowhere near having that level of confidence.
Here's why: There were probably only a small number of people in the room, while there would be many more listening to the webcast.
If trials had started, AVXL would have had to announce it and/or file an 8-K. Starting trials would be considered "material" under Reg FD and would have to be disclosed immediately.
Cash position at year end won't be announced until next quarterly announcement. Last year, fiscal 1Q was announced on Feb 7.
No proof reported in the medical literature that Sigma-1 upregulation has any demonstrable clinical benefit in humans. IMO, partnership highly unlikely without human efficacy data from late stage trials. Bar is higher due to extraordinary difficulty of treating CNS conditions and failure after failure of promising approaches.
For two years, Missling has sent messages of confidence about forging ahead. Messages, smessages. Fact is, track record is terrible. Look at what he does, not what he says.
AVXL announced an MTA with Biogen and half the posters on this board jump to the conclusion that a HUGE partnership or buyout is imminent. Fact: MTAs are done all the time and most never move beyond the original purpose, which is why they are almost never announced. Fact: Serious investors know hype when they see it and it's a turn off. Fact: AVXL did an MTA with Biogen 16 months ago and nothing further has ever been announced. Fact: For now, at least, the hype worked on the retail suckers. You're losing money while Missling is raking it in.
The market knows exactly who Anavex is and who Missling is. That is why the stock is languishing and there are no pharma partnerships and minimal institutional ownership (other than index funds).
No company is going to do a favorable partnership for a drug that shows no clear evidence of efficacy, especially for a very complex, difficult disease to treat. Remember, the phase 2a AD trial wasn't even designed to demonstrate efficacy. It was a safety and MTD study.
He's going because he has to keep mining for new suckers to buy the stock.
Bargain of the century or overpriced story stock? That is the question. Research on Sigma-1 was first published almost 40 years ago, so big pharma can't be unaware. Yet development of Sigma-1 antagonists for treatment of CNS diseases hasn't been a significant focus of big pharma R&D. Do you really believe big biotech/big pharma is either stupid or blinded by the not-invented-here syndrome? Anything is possible but...
Like I said, circumstances can vary and there can be exceptions. Maybe AVXL will be an exception. However, as an investor in biotech who has been burned a few times because I drank the Kool-Aid and denied what in hindsight seemed obvious, I prefer to take a more conservative approach.
Generally speaking, positive ph 2 or ph 3 data is the sweet spot though variety ofother factors can affect the timing and value of a transaction.
Pharma partnership not realistic at this time, except maybe at fire sale price. Not enough meat on the bone for big pharma. Big pharmas already aware (not that big a space). Not saying pharma partnership can't happen ever. But IMO late stage human data is prerequisite for acceptable terms.
Just expressing my opinion. I hope I'm wrong. Been burned before by tiny biotechs that appeared to have a miracle drug. One of those was NWBO. GLTA.
Pfizer is no longer in AD or PD. Didn't you hear about that?
"If it was a dud, we would have sold or partnered a long time ago."
If it was a dud, who do you think would buy it or do a partnership, and what do you think somebody would have been willing to pay? Your statement makes no sense.
Precision medicine has nothing to do with whether big pharmas do a deal with early stage biotechs (an exception might be for a platform technology). Please show me an example of a recent big pharma deal done at a premium with a very early stage biotech like AVXL. BTW, the MTA with Biogen involved no payment to AVXL, so this does not count as a big pharma collaboration. If that work had been fruitful, we'd have known about it long ago. MTAs are done all the time. Most end up going nowhere, which is why they are almost never announced. I believe AVXL announced it because shareholders would be excited about it, which is exactly what happened.
A Biogen collaboration is a pipe dream. Ditto for any other big pharma deal at this time. Data on AD phase 2a trial is ambiguous. Everything else is preclinical. Without compelling later stage human data, big pharma isn't going to step up. Anavex is going to have to continue to dilute current shareholders through LPC because it's their only source of ready cash. Meanwhile, they'll continue to put out BS announcements to keep hope alive.
Get real. "Tutes" are not going to buy a sub-$5 biotech stock that isn't in late stage clinicals. The "tutes" that currently own AVXL are index funds that track the Russell 3000, which includes AVXL. The minimum market cap for inclusion in the R3K in 2017 was about $144M. This can go up or down but figure about the same when the Russell Indexes are rebalanced in June. If AVXL is is below the minimum at that time, the stock will be dropped and the index funds will sell.
ABOUT IND - In the US, it is against the law to test an experimental drug on humans. An IND is essentially a request for an exemption from the law. The IND includes a substantial amount of information and data for review by FDA. The FDA does not actually approved INDs. If the FDA does not respond in 30 days, a company can start their trial. The fact that AVXL indicated they are expecting feedback from the FDA to finalize the clinical trial protocol for this study tells me that the FDA had an issue or issues that the company needs to address.
Post Hoc Analysis Hype Debunked: https://seekingalpha.com/article/1524342-post-hoc-analysis-hype-debunked
Here's why today's PR is a ruse. Last para from the article in J of Clin Hypertension.
The results of our post hoc analysis warrant cautious interpretation. BP measurement was not a primary goal of the trial. As such, there was no protocol in place regarding the method and timing of BP measurement across visits. We suspect that the initial decline in SBP between the first and second pretreatment readings was partly caused by differences in the timing, setting, and/or method of measurement. Understanding these important limitations, the significant SBP reduction appreciated in the adjusted analyses merits further, more focused investigation into sigma-1 receptor agonists as a potential future class of antihypertensive therapy.
The SP is down because today's PR is BS. Every time a BS PR is put out, the SP drops. The only thing investors care about is clinical trial data.
Interesting, except that AVXL is claiming to lower blood pressure, not bad cholesterol. This PR is an attempt to distract shareholders from the real issue, which is that there is no clear evidence of efficacy in humans in the treatment of any CNS diseases. Does the world really need another anti-hypertensive drug when there are efficacious anti-hypertensive drugs that cost pennies a day? Ditto for insomnia. You people are being conned.
There will be no IND filing for Alzheimer's since the company has said this trial will be done in Australia, not in the US. Ditto for Parkinson's. You really should get your facts straight before you sink your money into this con job.
Of the shares held by the "tutes" at 9/30, most are held by index funds. AVXL is currently included in the Russell 3000, so these funds must own a proportional number of shares. Among the top holders of AVXL, only Park West with 6.5% and Knoll Capital with 1.64% are actively managed. For 2017, the cut off for market capitalization for the R3K was $144M, which is right about where AVXL is now. While the minimum market cap for inclusion in the R3K varies up or down somewhat from year to year, I believe we are in real danger of being dropped when the Russell indexes are reconstituted in May. If AVXL is dropped from the R3K, all the shares held by the index funds will be sold within an extremely short period of time. So I think to be excited about the so-called progress with the tutes is therefore misguided. Finally, actively managed funds are very unlikely to buy shares of AVXL given that most of the fund managers will not purchase shares of a company that has not yet demonstrated efficacy in late stage trials. Unless and until AVXL shows both safety and efficacy in P3 trials, the funds are extremely unlikely to buy. IMO, it is highly unlikely that we will have efficacy data from late stage trials by May. If AVXL is dropped from the R3K, several million shares held by index funds will hit the market at about the same time and the stock will tank. Hope springs eternal but buyer beware.
The only secret strategy is pocketing your money while making you think they have the answer to all things CNS. Objectively, there is no meaningful human trial data, no peer-reviewed articles, no promised trials, FDA issues with Rett trial and no answers. All else is merely hype and hope. GLTA.
Pay attention the carefully crafted language: "...the Company anticipates dosing the first patient in due course following FDA approval of the IND."
In other words, this is open ended and could go on for some time. We don't know what the FDA's concerns are and we don't know what AVXL must to do to satisfy FDA or how long it could take.
Keep in mind that most biotech companies fail because of poor management, not bad science. Seems to me AVXL shareholders would benefit from having a CEO with a proven track record.
A dismal track record for 2017.
The lack of transparency and lack of communication with investors does not help. If there is nothing to hide, why act like there is?
Your statement is overly optimistic in my opinion. The data is very preliminary and not peer reviewed.
Really? I'm shocked by how high the stock price is. Seems to me 30 cents a share is about right. There is little evidence that A273 is efficacious and management has repeatedly failed over the last 2 years to meet any of its stated clinical trial objectives. Talk on this MB of a Biogen buyout is pure fantasy. The story keeps changing, history is erased on the website and the management regularly fails to communicate any real information. IMO, this company is a con and the shareholders are suckers. Hope is a poor way to invest.