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Good point. I'm still getting over the flu so part time in la la land. I was thinking of my Jan 19 2024 options. My bad.
4 weeks left.
The CC was pretty much like every other CC. Missling stuck to the PR. There was very little new information.
There was no bad news.
There was a maybe Rett TLD might be later than expected.
All the hype and high expectations were created on the board. The company didn't create those.
There are still 7 weeks left in the year. We will see what additional information comes out between now and then.
I just checked the 10K there were no subsequent events.
Oh wait..... Those shares are held by mindless index funds and mom and pop biotech investors. No serious biotech investors own Anavex we are told.
So it would seem that the market i.e. those who actually buy shares out of choice is very small for Anavex.
More likely, there are no big brokerage houses pushing Anavex for whatever reason so Anavex really is a small developmental biotech in a very high risk space that most investors know little to nothing about, nor should they.
Thanks for your take on that.
The trial ended June 30 2023. So that final safety visit would have been August 1 or thereabouts for a 30 day visit. That leaves about 4 months till current day.
Missling is suggesting that there is data that has not yet come from the CRO and that delay is due to "an additional safety visit". That suggests one later than the one you describe as the normal 15 to 30 day visit.
I guess we will find out sooner or later.
What are you complaining about?
That text came from the SA transcript.
My point was that the SAE, if there was one, has to be classified. That is a process. Until that process is completed they can't release the TLD.
You and I are saying very much the same thing.
He rewording of this reply suggests to me that he knows when it will be published.
"...We have met the European Agency several times in meetings and we have shared the data which is not yet published, which is the published date of -- the planned published communication of the full data of the Alzheimer Phase 2b/3 study.
Given that Missling said the OLE data was going to be part of the NDA package, I'd guess that was an outcome from FDA meetings. OLE data can be supportive but as I understand it, is not usually important enough to hold up filing and NDA
You may not like his choice but MIssling has said Rett FIRST.
So AD approvals are scheduled around that, at least in the US. Given the time line for EMA approval US AD is still likely to be first.
Interesting that Missling said multiple meeting with the EMA people not just the one. He PRs just the one that had hard decision/result.
I expect the same for FDA meetings.
If there was an SAE it has to be classified as to whether it is drug related or it is unrelated.
You're right, that wouldn't delay number crunching. It would delay publishing TLD until that issue is settled and can be reported in the TLD.
He said "preparing to initiate" on all the upcoming trials.
I'm taking that to mean setting up CRO's and the like, with "initiate" meaning starting patient screening.
That may be an optimistic view of what he said.
Also I heard that the AD OLE data is going to be part of the FDA submission so the OLE has to complete prior to submission.
As I understood his answer, the EMA got to see all the AD data when it made its recommendation. Is that what you heard?
He didn't really answer about AU.
As for the FDA and AD, Rett is first. If there is a delay on Rett that pushes AD back in the US.
Apparently operating the speaker volume control was a significant challenge.
That assumes that Missling is following the standard path.
There is little evidence for that.
History has shown that Anavex PRs generally result in a share price drop. No need to feed that dragon.
Welcome to the posting side of the board.
Anavex has been laying the foundation for quite a while.
The easy answer to that is, there is no evidence that 2-73 has failed. In fact, quite the opposite.
...why you are not accepting the fact that this drug has failed...
I quoted a study that looked at the data. I don't have their data.
Filing an FDA NDA is not material because the outcome is uncertain.
In a bit of research confirmed that 98% of companies do disclose filing an NDA. That research also disclosed that the time between the filing and the disclosure could be a few days to two months or more after the filing.
Data from 2010 thru 2016.
Of the 249 applications (188 NDAs and 61 BLAs), 222 (89.2%) were disclosed in at least 1 public medium (Figure), including in a press release for 196 applications (78.7%) (Table). Of the press releases, 196 (86.2%) were found on applicants’ websites. Of the applications, 157 (63.1%) were disclosed in SEC filings, including 136 (54.6%) in press releases and SEC filings. The overall rates of public disclosures increased from 87.5% in 2010 to 97.6% in 2016. Publicly traded companies were more likely to disclose applications in any medium compared with nonpublic companies (relative risk, 1.43; 95% CI, 1.09-1.90); private companies were less likely to disclose applications (relative risk, 0.70; 95% CI, 0.53-0.92) (Table). The median time to disclosure was 6 days (IQR, 1-63 days) for press releases, 55 days (IQR, 9-86 days) for SEC filings, and 6 days (IQR, 1-63 days) for any public media.
Sorry that my thinking doesn't pass your tests. I'll work on that.
I doubt that you are correct on that. My reasoning is that a similar meeting for Rett should have already been held and we have heard nothing about it. Maybe a similar meeting with the FDA on AD has been held or is scheduled. Again we have heard nothing about such meetings.
We shall see. It doesn't really matter either way. Things will unfold as they will no matter how we speculate.
Ah yes. MAA not NDA. I'm working through a case of the Flu and nowhere close to 100%. Thank you for the correction.
Missling has never been very communicative about meetings with the FDA. We mostly find out about them well after the fact and then only when the decision reached at the meeting becomes a point of serious contention in the public discussion.
We don't know exactly what data was presented to the EMA. Apparently enough data was presented such that the EMA thought it was worth filing an NDA and looking at the full NDA package.
The meetings and initial date presentation is the start of the approval process. The submission of the full NDA package can be 7 months in the future.
If that question is asked the company may not want to answer directly as part of its market surprise strategy.
Exhibit B.
I provided a piece of information. If that makes everything OK for you, great.
I found it an interesting overview of the current state of the developmental biotech space and thought others might find it interesting also.
Overall view of the small biotech industry slump this year.
https://techxplore.com/news/2023-11-biotech-slump-labs-threatening-drugs.html
NOVEMBER 24, 2023
Editors' notes
A biotech slump is emptying labs and threatening research on new drugs
by Gerry Smith, Bloomberg News
Credit: Pixabay/CC0 Public Domain
Sangamo Therapeutics Inc.'s cost cuts didn't hurt just the roughly 162 U.S. workers who lost their jobs this month. It's also a blow to Jerry Walter, who's lost five family members and suffered kidney, lung, hearing and heart damage from a rare disease.
Citing the "challenging economic environment" that's sending shock waves through the biotech industry, Sangamo paused research on an experimental gene therapy—possibly a cure—for Fabry disease. Walter, a 69-year-old retired U.S. Army colonel who's already had a heart transplant due to the inherited enzyme deficiency, said it's disappointing to see work stop on yet another potential new medicine.
"The promise of a better treatment keeps getting pushed down the road," he said.
Sangamo will finish a current Fabry trial as planned and is seeking a partner for help with moving its studies to the final stage, a spokesperson said. Yet it's been another bleak year for biotech companies as a closely watched index of stocks, often called the XBI, just passed 1,000 days from its early 2021 peak. The number of companies exploring strategic options—typically a sign of desperation—just hit a record high, according to analysts from Stifel.
"Nobody knows where the bottom of this is," said Sam Fazeli, an analyst at Bloomberg Intelligence.
Money for research is getting harder to find: New flows into biotech venture funds are estimated to fall to $23 billion this year from about $31 billion in 2021, the Stifel analysts said. Rising interest rates, threats to prices of new drugs and a post-pandemic letdown have forced biotechs to pull back on research and development.
Last year, global pharma R&D spending fell 2.2% to $244 billion, the first drop in a decade, according to Evaluate Pharma, and slowed growth is expected in the coming years. It was just the fourth such decline in almost four decades, according to the PhRMA industry group.
The sector has seen "serious slimming down of pipelines at the small end," Evaluate said in its August report.
Crucial work
Big drugmakers have increasingly moved into areas that used to be biotech's domain—like cancer and rare diseases—seeking profits from drugs that aren't easily replaced by competitors. French drugmaker Sanofi is boosting R&D spending, while Eli Lilly & Co., maker of blockbuster weight-loss drugs, increased this year's R&D budget by $600 million.
But the industry giants can't replace the crucial work done by smaller biotech companies, said Derek Lowe, a longtime drug researcher who writes the industry blog "In the Pipeline." In many cases, biotech companies handle risky early-stage research that big drugmakers may invest in if it shows promise.
Biotech companies often take on challenges that are a bit "out there," Lowe said. Big manufacturers "let the little companies take a crack at it and see how it goes."
Gone is the pandemic enthusiasm that drove COVID-19 shot-maker Moderna Inc.'s 12-month trailing price as high as 188 times diluted earnings per share from continuing operations in June 2021. Now the company is expected to report losses on an adjusted basis over the next year, and more than half the analysts covering it don't recommend buying shares.
An industry slowdown was inevitable, Fazeli said. Firms are shifting their strategies in response. Unable to find investors who can provide more funds, small biotechs are skipping the long shots to focus on sure bets that are more likely to generate income soon or attract a deal with a bigger drug company, said John LaMattina, a former head of R&D at Pfizer Inc.
That means less creativity in the sector that gave rise to COVID-19 shots, life-saving gene therapies and other treatments for once-fatal diseases. Those include Merck & Co.'s Keytruda, which first took shape about two decades ago at biotech company Organon & Co. Today the drug has treated more than 1 million patients with more than 20 different cancers, generating some $21 billion in sales last year.
Medicine paucity
"The concern is that in three or four years from now there will be a paucity of innovative medicines," said Jeff Jonas, former chief executive officer of the biotech company Sage Therapeutics Inc. "There is potential for the early ecosystem to suffer."
The impact is hitting companies like Charles River Laboratories International Inc. that does work including early safety research on rats that precedes human testing. The firm has been involved in studying more than 80% of all U.S.-approved drugs in the past three years.
Biotech companies that once investigated four or five products at a time now just have enough funding for two, said Jim Foster, Charles River's chief executive officer. The result: organic revenue is expected to grow about 6% this year, roughly half its 2022 level.
"People are reprioritizing, being more judicious," Foster said in an interview. "We are a canary in the coal mine."
Lab space vacancies in the Boston biotech industry hub have hit a 10-year high, according to the real estate firm Colliers. For the first time, there's about 5 million square feet of space on the market, up from 300,000 two years ago.
IRA fears
Biotech's woes could be a problem for big drugmakers, said Lowe, the pharma blogger: a smaller crop of candidates for big drug companies to buy later on. Those drugmakers need new products to make up for older ones that will be facing competition when their exclusivity runs out.
Aging drugs are also eligible for Medicare price negotiations under the Inflation Reduction Act, President Joe Biden's signature legislation. Drugmakers have said that the law effectively shortens their products' most profitable period, and that some early development programs will have to be sacrificed.
All that is bad news for Walter, the former colonel who founded the National Fabry Disease Foundation. Twice a month, the Hillsborough, North Carolina, resident sits for three hours getting enzyme replacement through an IV.
Before running short of money, Sangamo was pursuing a one-time treatment aimed at fixing the gene flaw responsible for the disease, meaning Fabry patients wouldn't need those twice-monthly infusions. Those who got it in a trial "continue to report improvements in their quality of life," the company said.
"We believe this is an important potential medicine and are doing everything in our power to still get this to patients in need," the Sangamo spokesperson said in an email.
The treatment could have been "revolutionary," had work on it continued, Walter said, adding he hopes that Sangamo can resolve its funding issues.
Would it make sense for the CC to be it's usual not much and then after the call to make any announcements?
The year end 10K is really about the past. Subsequent events are those between the end of the fiscal year and the publication of the 10K.
Get the CC over which clears the decks for new information.
As of 2022 10K accumulated deficit was $245,563,781.
With Missling, there is no predicting what he will do with the voucher.
It hits the books as an asset with about $100,000,000 value. He may want to use that asset value to help secure additional financing. He has said that as soon as possible he wants to use conventional bank financing going forward. Having that on the books should help secure a much better loan rate as it would be tangible collateral. At this point the company doesn't have much in assets other than Intellectual Property. A bank valuing 2-73 as a drug will have to be done once it is approved and generating an actual revenue stream. As we saw with the mabs recently approved, getting the drug on the market doesn't always translate into a big revenue stream and the banks know that.
You make a good argument except for ignoring what Missling has repeatedly said about Rett first in the US.
I'm Sooo proud of you.
What does that 12X1:GR mean?
Thanks for the reply. I wish you well in you endeavors.
Where did the 12/1 requirement come from? Missling said EOY.
Raja what is your thinking on that?
I'll be surprised if there is any significant short covering in that report.
Probably not a PR tomorrow. That is a holiday in the US. Not to mention the very negative spin you put on that "theory".
2-73 for AD will be considerably cheaper than the liquid form for Rett 2-73. My guess is the price for Rett treatment will drop considerably when AD is approved and there is a mass market for 2-73.
2-73 for insomnia maybe an occasional pill rather than an every day thing. We will have to wait and see what the price of 2-73 is for AD treatment.