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Cancer stocks are hot GLSI rockets 2000% on Phase 2 breast cancer study. Means moving to Phase 3 only.
What do people think NWBO will do on Phase 3 results that signal likely approval?
I have been watching developments in NWBO for a long time but did not start buying shares until you posted about it on the Anavex board. And started buying in the .60s and .70s here recently. On legal questions i don't listen to many posts as i can take my own counsel but know you practice in EU and are a credible poster.
As far as the current kerfuffle Companies fumble on disclosures negligently and intentionally so it is no assurance but I think NWBO would attempt to comply therefore I think there is a strong possibilty that NWBO will not ask for the statisticians to finalize the TLD report until the FDA has accepted the revised primary end point for the more important reason to avoid ambiguity. NWBO if they truly have a homerun will want everyone to realize the enormity of it at the first crack of the bat.
I must admit that if the trial met the revised endpoint but not the old endpoint on the US Clinical trial site then I think the NWBO can wait to release until it is finally accepted or rejected by the FDA.
That is right because Corporate management has affirmative duties to shareholders. The one we were discussing was duty to disclose the events that would substantially negatively impact the investment, in public traded companies it must be by SEC Form 8k. Four day rule.
For NWBO this is a little clouded as the FDA endpoint has not been updated and is different than the one in Germany for instance. So there is a strong possibility that IF (because they might not have it yet) they have the Statistical Report of the Data ( not raw data) from the 3rd party statisticians and it meets the revised endpoints but not the old primary on the US Clinical Trial site. Then they can likely hold onto it until the FDA accepts or rejects the new endpoint. However, if they were thinking ahead they may have told the statitician to not complete the report until endpoint was finalized with the FDA
Lets try this a different way. Forget contracts they don't come up in that hypothetical. I was using materially adverse events as "things that could substaintially negatively impact the value of the investment." We are stuck on this hypothetical as you either do not feel a reasonable investor would think report of failure of primary endpoint would negatively impact the investment or even if it did the company has no duty to report it to shareholders. I am not sure which. So let's try a new hypothetical to see if I can explain the concept to you.
Thus:
A Company (R) has one drug in clinical trials P3 and it is the lead compound and the future of the company rests with this one drug. R gets a report that a clinical trial participant has a AE that is possibly caused by the drug and he dies, arguments could be made that it was not the drug that cause the adverse reaction or death. It is reported to R's management. Does R have a duty to disclose this event to R shareholders? R is a publicly traded company. If they have a duty to disclose how should they do it and how long to they have to make the disclosure?
The fiduciary duty to promptly disclose materially adverse events in public companies is codified as 4 days. Your argument seems to be that a report from the 3rd party statistician that failure of the primary endpoint would not necessarily trigger a duty to disclose. I say it would.
Let's leave it there because if I agree with you we would both be wrong. Haha.
I am not saying that is giving any assurances that this means trial did not fail or is a reason to not sell shares. No it does not give any assurances and if someone thinks the company would not disclose they should be very afraid. If someone thinks management does not have these duties to shareholders they should not invest. If they think this particular company will not faithfully carryout these duties they should think about selling.
The duty is basic to public and non public corporate duties to shareholders. These duties are due shareholders in privately held corporations and fiduciary trusts as well. You are trying to narrow these duties with specific regulations. These disclosures are basic fiduciary duties of management to shareholders. In public companies there are further requirements on how these duties are carried out with public disclosures. It is not necessary to have any elements of fraud. It involves breaches of fiduciary duties of the managers (CEO and CFO) to the owners of the Company ( SHAREHOLDERS). The test is would a reasonable investor think that it is a materially adverse event.
No I am not. You are conflating the issue of a statistical test by a third party contractor with a judgment or analysis of data by the company or FDA. A third party statistician hired by the Company gives a report to the Company that the trial did not meet its Primary Endpoint. That is a materially adverse event in a Phase 3 trial of a Company's lead drug any "reasonable investor" would think so, that is the test.
Another such material event would be a fatal AE attributed to the drug.
No not asserting any such thing as "if they fail to disclose that means trial did not fail." I am simply stating if management gets a report from the statisticians the company hired to run the data against the end points and the Primary Endpoint fails then the Company had a duty to disclose that to shareholders. Very basic. There are no assurances that the trial did not fail. The company may not have the report from the statisticians. The Company could also breach the duty to disclose. Most likely is the report is not ready yet or has not been communicated to management.
That is not the hypothetical presented. The Company and the FDA are not involved in making any judgments or analysis on data in this hypothetical. Statisticians hired by the company run the data against the pre-determined primary endpoint as well as the all the secondary endpoints. There is no judgments or determinations of value to continue the trials or opinions of approvablity involved. Only this question. Did the trial meet the primary endpoint or not?
If not then there is no grey area and no judgments to make as the primary endpoint was predetermined and any reasonable investor would believe that was a materially adverse event.
The statisticians determine if the endpoint was met and communicate that to management. Management has a duty to inform the shareholders.
Failure to disclose material information that to the "reasonable investor" would substantially impair the value of the investment must be disclosed. Now if a company had one drug in Phase 3 and the value of the stock depended one trial the company was heavily invested in and that trial failed to meet its primary endpoint would a "reasonable investor" believe that negatively impacted the value of the stock? In such a case a court could direct a verdict for plaintiffs as it is such a plain and obvious failure of the company's duty to disclose materially negative highly impactful information. That is what is called a "bright line" test, no grey area there for the court to weigh.
Failure of the primary end point is well defined and failure of the primary endpoint would be a "bright line" material event requiring disclosure.
The data mining you are discribing would be something the company would do if they want to see whether or not they want to further develop the drug or seek approval even though the primary end point was not met. Failure to meet the primary endpoint is not necessarily a failure of the trial in whole if enough important secondaries were met but it would trigger an absolute requirement to disclose to shareholders that the primary endpoint was not met.
There is no room to beat around the bush about it but it would be reasonable to provide all the positive outcomes as well.
Instead of burdening yourself and the rest of us with your fears and since you say you have 100s of percentages of profits already why not sell a little or a lot but keep some as well in case your fears are unfounded.
Easy. Have an account balance of more than $25 million. That's the hard part though. Then one is not constrained by the FINRA regulations restricting the rest of us and the broker-dealer will allow unfettered trading.
Yes do not take the eventual collapse of the Curis stock price to be an example of what will happen after NWBO 400% gap and run after TLD because good data from NWBO will mean likely approval and a $5 plus share price. Then Institutions and big money investors will start to accumulate. There likely will be little if any drop from the initial pop just further accumulation to a $20-30 billion market cap. Any traders selling the pop hoping to buy back cheaper will either chase and have less shares or it will get away from them completely and they will kick themselves for the rest of their lives for letting the opportunity of a lifetime pass them. Further evidence that CRIS is just smoke and mirrors from HFT Algos is they are still running the price up after hours when after market close Curis announced a stock offering with no price yet. No one in there right mind would buy after that run when there will be a big drop tomorrow to the offering price. All that after hours volume in CRIS is most certainly computers wash trading and maybe catching a few noobs in the spider web trap.
CRIS has traded 280 million shares today when there are only 58 million total shares outstanding. How is that possible? Because it is only 2.8 million shares high frequency computer algo wash traded a 100 times to spike the price. Keep your eyes on this for an education of how the rigged stock market really works for HFT hedge funds to rob the market. This is nuclear weapon HFT Algos. Remember KBIO? This is likely how it will play out. Preliminary phase 1. Beware of the grassy knoll. Looks like an ambush, bigger than Dallas.
NWBO spike on TLD will be real because it will actually be meaningful. Phase 1s are meaningless they nearly always are good.
CYDY is up 28% on 5 x average volume with power hour left to go. Can you spell breakaway gap and run boys and girls? That dip to $2.88 interest was a good sign for a continued run tomorrow.
Intraday consolidation is good. It sets the stock up for further gains as it backs up to get some big players in for the long ride up over the next few days.
CVM has been doing well but CytoDyn is scorching the earth around the shorts on whispers of EUA for Covid19. When I take a few profits there I will load more NEBO. So I agree with your strategy. I was planning on parlay into the other one depending on which hit first CYDY or NWBO. I am thinking both will hit.
Well then God Bless you and all the Doctors and Caregivers and all the patients and families.
This is extremely good news for the elderly patients on Medicare as it looks like they will have early access. Nice since that is the demographic population most in need of it.
I wonder if the CDC has seen the Leronlimab S2C trial data. At least two of the other three already have EUA. I do not know about the 3rd one.
Remdesivir is missing I do not know if it was previously coded or not authorized for payment through Medicare?
At the very least I believe this tells the FDA "If you authorize EAU for Leronlimab then Medicare will reimburse for that use of Leronlimab in Medicare patients"
Yes is is for real. CDC has established 4 new codes for 4 new drugs expected to be used for Covid19. 3M Health Services published this same information on December 1, 2020. There is also 3 new codes for other drugs not known yet as place holders. Leronlimab is one of the 4 named newly coded drugs. Looks like the CDC is fairly sure Leronlimab will be used for Covid19 and at least Medicare will reimburse. Other Insurance and State Medicaid plans should follow suit.
Who would have losses they did not have last year? Don't you mean book profits?
Bingo!
You are right we won't know the recent stock sales until the next quarterly. I was referring to the run up from December 2019 to mid Feb 2020 where the prevailing stock prices went from $2.40s to $5s and higher. I was flabbergasted that Anavex sold no shares. So I thought it may have been that the lined up partnership with upfront cash for PDD. But they did not; the PDD partnership was for help with trial costs for PDD from the Australian PD non profit.
Missling may believe that Anavex has enough cash run way until RETT approval.
It will be interesting to see the stock sales activity at the next Q4 due next Tuesday December 15th.
Thanks for posting Biostockclub's excellent summation again. It is definately worth another read. In fact his post would be worth reviewing after the next readout as well. Development of blarcamesine is a construction process. Different pieces are being built in separate trials. Soon we shall see how they fit together across various correlations.
I hope Anavex just focuses on RETT approval processes and other rare developmental and degenerative indications after that. These will be plenty profitable to fund the ALZ and other indications going forward. It seems Missling may be somewhat banking on revenue from RETT as there seems to have been a hiatus in utilization of the financing facilities.
Insider Financial is taking a big swing with the violet upsurge price prediction. Everyone is expecting a strike out with the Dec 10th CC. So if the CytoDyn connents with anything positive and new it could hit like a Bo Jackson type HOMERUN.
I think that you are correct in that each indication must be supported in trials for that indication.Adult RETT I believe is the first one they will file a NDA on first. One indication three trials. They maybe be able to use some of the Ped RETT for Adult as same indication just different age group.
Great post. I think it is fairly evident that all of the clinical trials of blarcamesine are meant to fit together as building blocks for the construction of the NDA application data for each of the indications. With each trial having its own structural components to add to the whole. Whether or not one single trial could stand on it's own; when fitted together they may build a bridge to regulatory approval.
Yes I Definately agree with this. Nothing FDA can take action on if it has not been applied for by the company. A better target would be Nader and the BOD. Or Govt funding sources like NIH and OWS. Wasting money on lesser drugs because of crikey capitalizism.
Any shareholder that owns over 5% of the stock would also be defined as an Insider I believe. I am sure most if not all large holders like that would also be warrant holders.
I am thinking it might be because many of the warrant holders fit the definition of insiders and they would be possibly then making trades by receiving extra warrants with inside information.
Good post and i agree except it does not take $5 mil to 10 mil of capital to hammer down. Just 50 to 100k long shares wash traded 100s of times a day with HFT algos. They can also hammer it up. Over time the price reverts to the mean of the channel of the VWAP based on fundamental risk/reward valuation in the estimation of the composite of the shareholders. This of course fluctuates over time dependent on fundamental developments. The effect of the smoke and mirrors on the vertical price action by HF wash trading is designed to fool other market participants in to thinking the fundamentals have changed so they end up selling to cheap or buying to expensive.
Hence mean regression channel theory. When fundamentals meaningfully change the slope of the channel will change and there could be a reset to a different VWAP on a longer term time variable. HFT can only control the vertical axis and price will revert to the mean on the time axis.
Interested to see what they have shown so far in development. Looks like they IPOed just a few months ago. Most successful Biotechs take ten years or more to do well for investors. This might be worth a look however, bearing pending IPO lock up period expiration of course.
There is only one universal script for any ticker being played when one controls the vertical axis. If shares want to be sold the price is HF wash traded up to sell higher and if shares want to be purchased HT wash trade the stock low as possible to accumulate shares.
One can examine this phenomenon in real time by tracking the developments in Sage Therapeutics over the coming months. Look at the deal they did with Biogen, what the Wall Street fork tounges are saying and what the Institutional holdings show what really happened a few months from now when holdings are reported. Likely though before you see those holdings the stock will be at 52 week highs. The vertical axis shows selling but likely SAGE will soon undergo heavy accumulation.
Very good post and I agree with your deduction of the reason for the presentation. It seems Missling may have been employing stratagem in this presentation. Therefore no grandiose movements of the "queen piece." Coyness as overture to courting.
Given the stage of development of the pipeline and the need to partner on the ALZ indication, this courting overture would seem timely.
Oft rumoured suitor Biogen has been actively courting partnerships to hedge it's Aducanumab investment. First Denali partnership on drug licence and stock investment. Now just recently a partnership with Sage Therapeutics again with a stock purchase as part of the package. Former statements from Missling leads one to reason that this would be the type of partnership he would prefer for blarcamesine. There is the ten million of authorized but not issued preferred AVXL shares that could allow for some flexibility in that regard. I don't think the suitor will require full results on blarcamesine for ALZ to do a partnership. The Biogen/SAGE deal was for a MDD drug the did not fully meet the endpoints of first Phase 3 trial and still several months for readout in the current MDD Phase 3, but netted SAGE $1.5 billion upfront ( half stock purchase and half cash payment ) and possible milestones of an additional $1.5 billion.
Things could get very interesting very quickly or could take a year or more for the courtship to get hot and heavy.
But I think Missling signaled there will be no peaking at the petticoats until Avavex gets the engagement ring.
That article is a paid advertisement by ONCY. But nice to be mentioned for free.
Appreciated. It seems like many trace minerals may be important. I am somewhat concerned about bioavailability of mineral pill supplements. Many modern food supplies may lack minerals in vegetables as well as a result of being grown in mineral depleted soils. Maybe a good source could be things like clorella and blue green algae.
ATHX is in Russell indexes.
Blarcamesine will likely sell very well when it gets approval for a widely distributed malady like sleep disorder or depression/anxiety. They are trying the harder indications first. They knew much less about the drug when they first targeted ALZ then RETT and PDD. Narrow focus on cognition in ALZ an extremely hard to hit target but a big payday and led to investor excitement which help raise funds. There is no doubt in my mind that blarcamesine will be a widely useful drug.
Two of the reasons it should be commercially successful are of course the all important safety profile and the second is its tonic effects. A mild tonic for better sleep and mood. Homeostasis is related to the concept of tonic effects in an elegant way in that both are a balancing function. The sheer genius of Anavex investigations are that it is showing that by balancing cellular processes by influencing the Sigma One in a specific way leads to balance in the overall function of the organism, they showed that convincingly in murine organisms now they are proving out those concepts in human organisms. Once blarcamesine is proven for one of these narrow hard targets they can go after the wide targets of sleep and mood. Other hard targets will come into focus as well. Success with RETT will lead to serious funding for the blockbuster Epilepsy Indication. This is where I see that blarcamesine may have a huge impact.
No matter what else there should be a market for a tonic like drug that improves mood and sleep while being safer than alternatives.
Examining investments based on FAITH seems problematic. But what is described in the post is Trading not investment. Maybe instead of examining Faith in a ticker one should examine Faith in one's trading abilities. If one wants to win the lotto they should buy lotto tickets not stocks. Is the inevitable failure of the "get rich quick" mindset apparent yet?