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I agree with this analysis.
similar successful biotechs I have invested in with paradigm shifting technology have followed a path where they languish for years at low market cap during development stage where at some point enter hockey stick like growth in a year when the market realizes the potential even before the big earnings and approvals. I have never had one that was a BO reset of market cap or quick short squeeze. But for those that develop as Independent Companies looking at 20 year charts can lend perspective. I had GILD at $10s ( $2s adjusted for forward splits) in 2000 where it slowly grew for a few years. It was 4x in about 24 months. But 10x in 60 months. But the big hockey stick growth did until 2012 to 2015 where is went from $20 to 100 in 30 months. If one was committed and just held ( the way my Sister did with her early Tesla investment) the gains were astonishing and nary a taxable event just a large estate of many shares more than one started with.
CytoDyn might be a similar type investment fo those with a similar very long term investment horizon. For an example of a more recent one still in development stage and still in early years of growth with hockey sticks in 2018 and 2019. Look at the 20 year chart of Arrowhead Pharma. I think CYDY is where Arrowhead was in 2017-2018 where I built positions. I major tech shift with its gene silencing lead to major growth in market cap before its first approval. I am expecting major early development hockey sticks for CYDY like ARWR but both ARWR and CYDY have the potential to develop later profit growth later mature hockey sticks like GILD a few years 5-10 beyond the early growth. 20 year charts help keep the long term investors focused on wealth building rather than get rich quick attitude where one can miss the real growth and cause tax events along the way. CYDY can be teens to 20s in 24 months but $60-100s in 60-72 months.
Good point. One would think that Merck would want to know how the Combo trial with Keytruda was panning out as well as NWBO as it would increase the BO offer.
I believe the placebo arm receives standard of care as well as the water shot.
Good post. Add to this the wide and deep moat of a 15 year trial with new much higher bar to show non inferiority for any new contender. By the time that is finished for the new drug DCVAX may have approval in many other indications from much shorter expansion label trials as Merck has done with Keytruda.
Brilliant post. Yes DCVAX is a paradigm shifting technology in cancer like Qualcomm was to communications technology and mobile semiconductors.
When the market finally catches on the stock will go into orbit faster than you can say "Snapdragon."
I am not keen on buying puts but NVCR puts are looking tasty at this level when the big disruptor NWBO soon might suck all the air out of the room with spectacular results and goes on to dominate the market.
Yes absolutely. On BO it could be 2000-4000%. On licence deal 1000% or more. All overnight. With out those could get similar over a 6-24 month time frame.
"Short with no risk" Does not exist. Risk is unlimited. Tremendously risky to short a stock being run by computer Algos. The only one with reasonable risk is the hedge fund running the HFT algo.
There is the possibility that the silence is a mandated quiet period. For instance is there is a BO or licensing deal contingent of trial outcome.
Stellas cancer drug is similar to the Greenwich drug. Sympathy trade and likely a better buy in my quick glance opinion. GLSL might be a HFT trading pump ...they can keep it going for a while but then again they might be pricing in an approval based on the results of P2. But there are always bumps in the road.
NWBO has only the delay to contend with and therefore is a much superior investment currently then either of those. No where to go with GLSI but expecting a 5x bagger at least within months on NWBO.
Hopefully soon NWBO will become the hottest of the hot, not in terms of % increase because of the high share float but in terms of billions of dollars added to the market cap.
Yes I think that is an excellent strategy. It is what I use as I am much better at picking long term winners than short term
trading or market timing.I like to average into a stock over a years or several years buying dips every couple of months maybe sell a few blow off tops. Paying close attention to trading channels and resisting the urge to chase or buy a stock for a short term trade. I will average up or average down, for some reason averaging up feels better, but still near bottom of the channel.
Computer Algos gone crazy! Congratulations on dipping your cup into that slot machine as it went haywire and spilled all the money out. About time someone grabbed some off of those computer algo crooks.
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.