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He's not on ST, he's on Yahoo
Interesting...don't usually follow yahoo but purely based on looking at this persons posting history they seem fairly legit rather than someone who would make something up but can't say for sure of course.
"However, the FDA has acknowledged that it may take longer to establish clinically meaningful treatment effect among patients with early Alzheimer’s due to the very limited (if any) cognitive and functional deficits seen at those stages of disease. Additionally, many tools often used to measure functional impairment in patients with later stages of Alzheimer’s may not be able to identify subtle changes in early-stage disease, the agency explained.
Given these two factors, the FDA is considering other approaches, including endpoints based on cognitive assessments or surrogate endpoints, which may allow for shorter trial durations in the earliest stages of disease.
Direct measures of clinical benefit or validated surrogate endpoints may support a traditional approval, according to the FDA, while surrogate endpoints or intermediate clinical endpoints that don’t directly measure clinical benefit but are considered reasonably likely to predict clinical benefit may support the case for accelerated approval."
https://www.fiercebiotech.com/biotech/new-fda-guidelines-consider-amyloid-reduction-reasonably-likely-predict-clinical-benefit?utm_medium=email&utm_source=nl&utm_campaign=LS-NL-FierceBiotech&oly_enc_id=5901F6483778B1Z
People saying that the presentation is short at 15 mins but if it's mostly about the brain loss reduction finding of which we only really know the p value and have a visual of the the p values in different brain regions then it's hard to see how there wouldn't be new info with 15 mins mostly on this topic?
If as you say their drug candidate is no good can you say which are the "good" AD drugs patients should be having instead?
Dr Marwan Sabbagh clearly wasn't hired for RETT. He said the following: "I’m excited to join Anavex’s Scientific Advisory Board at this time of important progress of the Company. There is such a significant unmet medical need around the globe caused by Alzheimer’s disease and given the robust clinical data of blarcamesine (ANAVEX®2-73) in Alzheimer’s disease I look forward to joining the scientific team at Anavex to move forward a path for patients and their loved ones to be able to provide an effective therapeutic which can be taken orally and is generally safe.”
Even if there is not a perfect correlation it would seem overall studies recently have tended to find an around 60-80% correlation between plasma Aß42/40 and global amyloid burden measured by PET (according to google gemini). Therefore I would says it is worth more than a "regulatory side note". It would be rather crazy for Anavex not to mention the differences with competition even if not a perfect comparison.
Mayo noted on stocktwits that it did 73% better than Lecanemab at 52 weeks and about 60% better than Lecanemab score at week 72. So this wasn't a slim impovement even if only measuring something with a 70% odd correlation.
Obv this is ignoring the other biomarker of brain volume loss reduction in blarcamesine in the dosed group vs placebo with a 5 in 10,000 chance of this being due to chance. The Mabs instead shrink the brain quicker than placebo.
Yes that's the same chat GPT release I'm using. I am in UK but prob makes no difference.
https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/pre-authorisation-guidance
If you scroll down to section 2.2 here titled "how and when should the eligiblity request be sent to the EMA it says this - "The eligibility will be evaluated on a case-by-case basis by the EMA/CHMP. The applicant will, in all cases, be informed of the CHMP opinion, the week following the CHMP meeting where the discussion took place."
In section 2.3 here it's titled "dates for submission of eligibility requests" and below it has "Deadlines for submission of eligibility requests and dates of CHMP meetings, as follows:" So clearly CHMP is indeed involved at this pre-application stage.
Hi Joseph, there's quite a lot there so I'd have to look more into it but surely you have to go with the Anavex pr itself that clearly states CHMP are involved? - "the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) agreed that oral blarcamesine for Alzheimer’s disease is eligible for submission of an application for a Union Marketing Authorisation in the EU under the European Medicines Agency’s centralised procedure.".
This is why i plugged this into Chat GPT with the various questions. You also said chat CPT doesn't know what a SER is but from what I can see it does I asked it this -
what is the submission of eligiblty request with the ema?
Chat GPT - Submission of eligibility request with the European Medicines Agency (EMA) typically refers to the process by which pharmaceutical companies or sponsors seek to determine whether their medicinal product meets the criteria for being eligible for evaluation by the EMA. The EMA is responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the European Union (EU).
When a pharmaceutical company or sponsor intends to seek marketing authorization for a medicinal product in the EU, they must first submit an eligibility request to the EMA. This request includes information about the product and its intended use, along with supporting documentation. The EMA then assesses this information to determine whether the product meets the necessary criteria for evaluation.
The submission of an eligibility request is typically one of the initial steps in the regulatory process for bringing a new medicine to market in the EU. Once the eligibility request is approved, the pharmaceutical company or sponsor can proceed with submitting a marketing authorization application (MAA) to the EMA for full evaluation.
It's important to note that the specific requirements and procedures for submitting an eligibility request with the EMA may vary depending on the type of product and the regulatory pathway being pursued. Therefore, companies seeking to obtain marketing authorization for their medicinal products in the EU should closely follow the guidance provided by the EMA and consult with regulatory experts to ensure compliance with all applicable regulations.
I don't think she introduces herself but is hard to hear think she just says at start "Erm I have one".
It actually had someone ask questions who didn't sound clueless for once.
All the more reason for the CHMP not to have deemed blarcamesine eligible to apply if they rarely allow neurodegenerative medicines to go through to be assessed but they did deem them eligible.
You can try and adjust by adding bull or bear reasons on top of the 85% but then it just goes back into the debates already gone over.
For instance I could point how great a lot of Anavex hires are with Dr Marwan Sabbagh one of the n.1 ppl in the field joining and saying - "I’m excited to join Anavex’s Scientific Advisory Board at this time of important progress of the Company. There is such a significant unmet medical need around the globe caused by Alzheimer’s disease and given the robust clinical data of blarcamesine (ANAVEX®2-73) in Alzheimer’s disease I look forward to joining the scientific team at Anavex to move forward a path for patients and their loved ones to be able to provide an effective therapeutic which can be taken orally and is generally safe.”
There is also Professor JIn in terms of the stats element.
Then you have a phase 3 finding of them reducing brain volume reduction in the dosed group vs placebo with a p value of 0.0005 (or 5 in 10,000 chance that this result was down to chance).
Therefore considering all this the approval chance should be increased from 85% to 98%.
As I said it just becomes a pointing out a bullish/bearish arguments repeat the same way all the companies who applied for EMA had bullish and bearish points. Hence without more info on all the other companies it would seem easiest to go with the 85% known figure based purely on historical EMA approval rates.
"Once a company has submitted a drug application with the EMA, what their chances of being approved if going purely by the stats of the number of applications that get approved. On this basis only would it be more or less likely?"
Chat GPT - "The approval rate for drug applications submitted to the European Medicines Agency (EMA) can vary depending on several factors, including the quality of the application, the nature of the drug being submitted, and the regulatory requirements. However, if we're purely considering historical statistics of the number of applications that get approved, it would be more likely for a company to have their drug application approved by the EMA.
The EMA employs rigorous review processes to ensure the safety, efficacy, and quality of medicines before granting marketing authorization. While some applications may be rejected or require additional data or adjustments, the majority of applications that reach the submission stage have already undergone extensive preclinical and clinical testing to demonstrate their safety and efficacy.
Historically, the approval rate for drug applications submitted to regulatory agencies tends to be relatively high, particularly for applications that have successfully completed earlier stages of development and have been deemed eligible for submission. However, it's important to note that each application is evaluated on its own merits, and past approval rates do not guarantee success for any specific application.
Ultimately, while historical approval rates can provide insight into the likelihood of approval, numerous factors influence the outcome of a drug application, and each case is unique. Companies must ensure that their applications meet the necessary regulatory standards and provide robust evidence to support the safety, efficacy, and quality of their drugs to maximize their chances of approval by the EMA."
Doc Chat GPT isn't perfect but it's still useful. If can get misled if questions become too leading.
"A pre revenue company has just announced that the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) agreed that the companies drug is eligible for submission of an application for a Union Marketing Authorisation in the EU under the centralised procedure. How often would it be that such a company would not then submit an application?"
Chat GPT - "It would be relatively uncommon for a pre-revenue company to announce that the CHMP has agreed that their drug is eligible for submission of an application for Union Marketing Authorization in the EU under the centralised procedure and then decide not to submit an application.
Receiving eligibility from the CHMP is a significant milestone indicating that the drug has met certain standards of safety, efficacy, and quality required for submission. Typically, companies invest considerable resources, time, and effort to reach this stage in the regulatory process. Not proceeding with the application after such an announcement would be unusual, as it would mean foregoing the opportunity to obtain marketing authorization in the lucrative EU market.
However, there could be exceptional circumstances where a company decides not to proceed with the application despite receiving eligibility from the CHMP. These circumstances might include strategic shifts within the company, unexpected developments in the market or regulatory landscape, or significant challenges in the drug development process that make further investment untenable. While such cases are possible, they would likely be relatively rare compared to the number of companies that proceed with the application after receiving CHMP eligibility."
One final similar but differently phrased question:
"How impressive do results have to be for a pre revenue drug company to have the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) agree that their drug is eligible for submission of an application for a Union Marketing Authorisation in the EU under the European Medicines Agency’s centralised procedure? Do they have to be impressive or could they be average or slightly ambigious?"
ChatGPT
"For a pre-revenue drug company to have the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) agree that their drug is eligible for submission of an application for a Union Marketing Authorisation in the EU under the centralised procedure, the results typically need to be both clinically and statistically significant. While there is no strict definition of "impressive" results, they generally need to demonstrate clear evidence of the drug's efficacy, safety, and quality.
Here are some key considerations for the CHMP's assessment:
Efficacy: The drug's efficacy should be demonstrated through well-designed and adequately powered clinical trials. The results should show a meaningful improvement in patient outcomes compared to placebo or standard of care, with statistically significant findings. While the degree of improvement required may vary depending on the disease area and the severity of the condition, the CHMP typically looks for evidence of clinically relevant benefits.
Safety: The safety profile of the drug is critically important. While no drug is entirely without risks, the benefits of the drug should outweigh its potential risks. The clinical trial data should provide robust evidence of the drug's safety, including an assessment of common and serious adverse events, as well as any long-term safety considerations.
Quality: The drug must meet rigorous quality standards to ensure consistency, purity, and potency. This includes adherence to Good Manufacturing Practice (GMP) regulations and comprehensive documentation of the drug's manufacturing process, formulation, and stability.
Regulatory Compliance: The drug's development program must comply with relevant regulatory guidelines and requirements set forth by the EMA. This includes adherence to Good Clinical Practice (GCP) standards for clinical trials, as well as compliance with regulatory requirements for nonclinical studies and data submission.
While the results don't necessarily have to be groundbreaking or revolutionary, they do need to provide compelling evidence of the drug's efficacy, safety, and quality. Results that are average or ambiguous may not meet the CHMP's criteria for eligibility for submission of a marketing authorisation application.
It's important to note that the CHMP conducts a thorough review of all available data and considers the totality of evidence when making its assessment. Companies should strive to present a comprehensive and robust package of data that supports the potential approval of their drug for marketing authorisation in the EU."
I also asked this question, it appears chat GPT disagrees with Adam F -
"Is it a significant step for a pre revenue drug company to have the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) agree that their drug is eligible for submission of an application for a Union Marketing Authorisation in the EU under the European Medicines Agency’s centralised procedure or is this something that any company with an average or even fairly poor phase 3 trial could achieve and announce perhaps to get their share price up in the short term and keep investors off their backs?"
This is the answer - "Obtaining agreement from the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) that a drug is eligible for submission of an application for a Union Marketing Authorisation in the EU under the centralised procedure is indeed a significant step for a pre-revenue drug company. It represents a validation of the drug's potential and the company's development efforts.
However, it's essential to understand that achieving CHMP agreement is not a trivial matter, nor is it guaranteed for any company, especially if the phase 3 trial results are poor or average. The CHMP evaluates a range of factors when considering eligibility for submission, including the quality of clinical data, the benefit-risk profile of the drug, compliance with regulatory standards, and therapeutic innovation.
Here are some reasons why achieving CHMP agreement is significant:
Rigorous Evaluation: The CHMP conducts a thorough assessment of the drug's clinical data and overall development program to determine eligibility for submission. This evaluation involves expert review and scrutiny of multiple aspects of the drug's safety, efficacy, and quality.
Regulatory Endorsement: CHMP agreement provides regulatory endorsement of the drug's development program and its potential for marketing authorisation in the EU. This endorsement carries weight and credibility within the pharmaceutical industry and among investors.
Market Access: Submission of a marketing authorisation application under the centralised procedure enables access to the entire EU market, streamlining the approval process and potentially accelerating time to market for the drug.
Investor Confidence: While announcements of regulatory milestones may influence short-term market sentiment, achieving CHMP agreement signifies progress towards a tangible regulatory milestone and can enhance investor confidence in the company's long-term prospects.
Strategic Partnerships: CHMP agreement may also attract potential strategic partners or licensing opportunities, as it signals the drug's advancement towards market approval and commercialisation.
While it's true that companies may seek to leverage regulatory announcements to manage investor expectations or influence market sentiment, achieving CHMP agreement is a significant milestone that requires genuine progress and adherence to regulatory standards. Companies cannot achieve CHMP agreement without substantial evidence supporting the quality, safety, and efficacy of their drug candidate."
I asked chat GPT this question - "If a pre revenue company announces that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has deemed their drug as eligible for submission of a Union Marketing Authorisation in the EU under the centralised procedure. What would be the chances that after this that they don't then submit an application?"
This was the answer - "If a pre-revenue company announces that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has deemed their drug eligible for submission of a Union Marketing Authorization in the EU under the centralized procedure, the likelihood of them not submitting an application would typically be quite low.
Such an announcement indicates a significant milestone in the drug development process. It suggests that the company's drug has met certain regulatory criteria and is deemed suitable for further evaluation towards marketing authorization.
However, despite this positive step, there could be reasons why a company might ultimately decide not to submit the application:
Strategic Decision: The company might undergo strategic shifts or reevaluations that lead them to deprioritize the drug candidate or decide that pursuing marketing authorization is not aligned with their long-term goals.
Financial Constraints: The costs associated with preparing and submitting a marketing authorization application can be substantial. If the company faces financial challenges or is unable to secure sufficient funding, they might be forced to postpone or cancel the application.
Regulatory Concerns: Even though the CHMP deemed the drug eligible for submission, the company might encounter unforeseen regulatory challenges during the application process. These challenges could be related to clinical trial data, manufacturing processes, or other regulatory requirements.
Clinical Trial Results: If subsequent clinical trial results are unfavorable or raise safety concerns, the company might reconsider submitting the application.
Market Considerations: Changes in the market landscape or competitive pressures could also influence the company's decision. If they believe that the market opportunity for the drug has diminished or if competing products offer better prospects, they might choose not to proceed with the application.
While it's possible for a company to decide not to submit an application after receiving positive feedback from regulatory authorities like the CHMP, such instances are relatively rare. Typically, when a company makes such an announcement, it indicates their intention to move forward with the application process unless significant obstacles arise."
Check the BIVI sp...wonder what move could be here when it gets re-iterated to the market by Dr Grimmer that AVXLs drug decreased brain volume reduction in dosed patients with a 5 in 10,000 (or 1 in 2,000) chance that this result was due to chance (p=0.0005).
I think FDA will look at whole picture in regards to RETT.
The placebo group did even better than the trofinetide drug arm which obviously went on to be approved. The Blarcamesine group did slightly better than this placebo but not enough to be significant.
The approved Trofinetide also one could argue may have had an un-blinding effect against their own placebo group, with 60% odd who the highest dose in the phase 2 having diarrhea. This was the lowest dose used in the phase 3 which led to 80% odd having diarreah, fairly sure this would have been a symptom to look out for.
I can't really see why the placebo should have done so much better for Blarcamesine than Trofinetides beyond randomness, unless Blarcamesine was inspiring more hope in people than Trofinetide. Perhaps that might go to show the excitement the drug is giving in regards to results in Alzheimers etc.
FDA will look at the data and think the best thing for RETT patients is to be on Blarcamesine trials...as drug arm or placebo they will be better off than the currently approved drug.
Also the adult trial was a success. There was some controversy with the end points however the company essentially stated the clinical trials site should not be relied upon as it's too slow and isn't actually mandatory. This was actually illustrated again with the girls trial as the clinical trials site actually only had the RSBQ end point not CGI-I so would have actually made them the trial look better.
""We could get a big upside surprise coming out of left field but it sure doesn’t feel that way."
Pretty sure you aren't meant to "feel" a surprise coming out of left field before it happens.
"Extensive past experience in Phase 1-4 trials (especially for Phase 3 confirmatory trials and Phase 2 POC trials) and in successful regulatory submissions (including 8 US NDA/BLA, 2 MAA submissions and 1 China submission) involving in 10 different compounds, of which, 8 are all on market now; and extensive experience in project (internally-supported or/and with vendor CROs) and people management."
From linkedin bio of new hire.
I never said "proven" stronger, merely that the effect size improvement was larger than trofinetide drug arm. I thought you prided yourself on being careful with your words? Perhaps it doesn't apply to reading others words.
Obviously I'm aware that the placebo did very well as has been gone over many a time on here, I was merely saying the FDA would likely note overall effect change as an absolute measure plus the smaller placebo and the adult trial was a success hence in up in the air what will happen with RETT.
It could be that no trial is needed again with the effect size improvement being so much stronger than the approved Trofinetide. The smaller placebo group in Excellence trial was more effective than Trofinetide. Also obviously the adult trial was successful.
Kaufmann will make his points in regards to the trial and I think he will have weight with the FDA due to his expertise with RETT even if officially speaking the FDA shouldn't be influenced by this.
Kaufmann bio in regards to RETT:
"Dr. Kaufmann’s major focus of has been Rett syndrome, a field where he has published extensively on neurobiology and clinical aspects. He served as founder and leader of RettSearch, the international consortium of Rett syndrome clinical researchers. As such, he co-authored the current diagnostic guidelines for the disorder. He also edited the first clinical textbook on Rett syndrome, published in late 2017. Dr. Kaufmann has also served as Co-Principal Investigator of the NIH-funded Natural History Study of Rett syndrome (RDCRN program). Currently, he leads the Rett Syndrome Molecular Biomarkers Working Group for the Rettsyndrome.org foundation and the Rett Syndrome Behaviour Questionnaire Working Group. Dr. Kaufmann has played different roles, including site investigator, Principal Investigator, and DSMB member/chair, in almost 20 drug trials for neurodevelopmental disorders. In this context, he has been involved in virtually all neurobiologically-based drug trials for Rett syndrome.
Dr. Kaufmann has published more than 220 journal articles, most of them original publications. He has also served on several editorial boards and as reviewer for over 100 scientific journals."
I asked you before what drugs AD patients should take instead and you said something like I don't know, I'm not a neurologist. So I'm not sure you're an authority on what is likely or not to be approved.
There has been other news in the year - Dr Jin and Dr Sabbagh both joined, both highly respected within the alzheimers field. It's hard to think of better people to get on your team for a company trying to get an alzheimers drug to market.
Also findings such as the reduction in brain volume loss with a 5 in 10,000 chance that the drug arms reduction was due to chance.
I'd agree you could say at the $30 dollars a share jump it wasn't rational though I suppose if people had started to believe more in the full blown bull thesis at that moment then it was rational (or even too low a sp considering the potential in this narrative). Equally in this moment it seems people are believing more in the full blown bear thesis and momemtum has swung that way with the sp.
I'd say someone more negative on Anavex' future would be more likely to view the current lowly price as "rational" and "objective".
"Irrational exuberance backed by no news at all"
Equally when the sp is this far down it can also be called irrational negativity (or exuberance for those short). There has been negative RETT news but also positive news in regards to the EMA which is far more potentailly impactful to Anavex than Rett.
"but the notion that an army of posters is here to minimize him is a sad commentary".
Is it sadder than the notion put forward instead that there are a bunch of posters with no position who spend their free time posting here 24/7...
Equally though what is the benefit of putting some of it out initially to probably be critized by Adam Feuerstein etc if they know it will be released in the peer review journal reasonably soon. It would make more waves so to speak to put it out in one release, potentially get in the newspapers etc.
I do share the concern however but feel confident with them having professors such as Dr Jin and Dr Sabbagh plus the data was seen by EMA who said they can proceed to an application.
"Foul balls include his deer in the headlights response when an analyst asked about the lack of a Parkinson's trial update".
To be fair, if you mean the most recent call the analyst seemed a bit unprepared and seemed to not know how to ask a question. He kept cutting out and said "oh boy" and then barked "parkinsons trial" or something like that, which sounded more like a statement than a question. It was fair enough for Missing to be confused because everyone was.
To remind what Dr Sabbagh said when he joined as chairman of scientific advisory board in Sept - "I’m excited to join Anavex’s Scientific Advisory Board at this time of important progress of the Company,” said Professor Dr. Sabbagh. “There is such a significant unmet medical need around the globe caused by Alzheimer’s disease and given the robust clinical data of blarcamesine (ANAVEX®2-73) in Alzheimer’s disease I look forward to joining the scientific team at Anavex to move forward a path for patients and their loved ones to be able to provide an effective therapeutic which can be taken orally and is generally safe.”
Dr. Sabbagh is a leading investigator of many prominent national Alzheimer’s prevention and treatment clinical trials. He serves on the editorial boards of the Journal of Alzheimer’s Disease and Alzheimer’s and Dementia: Translational Research & Clinical Interventions. He is the editor-in-chief of Neurology and Therapy. Dr. Sabbagh is a prolific author who has written and edited books on Alzheimer’s disease and has contributed to hundreds of medical and scientific articles.
There is less political pull in Europe. Also in terms of effect size people take things like Gingo Biloba on the thinnest of evidence of efficacy that it might help their brains. You don't think they would take a pill that found a reduction in brain volume loss with a 5 in 10,000 (1 in 2,000) chance of the result being due to chance?
You say "it doesn't take a rocket scientist" but many a biotech runs out of money and go bankrupt or end up with gigantic dilution whereas he has kept the cash relatively high with no debt for a fair while without that much dilution.
Lol Kund you mention Missing in every post including this one. Ppl make a few posts about Dr Jin and you already say "too much talk about Dr Jin", prob coz even you concede he is a decent hire as head of Anavex Biostats being a "Former FDA Lead Neurology Statistician" so you don't want to talk about him.
Dr Jin only joined in March 2023. However he oversaw the Sept 2023 PR which found that the primary ADAS-COG end point had a 2.26 in 100 chance that the improvements in drug arm were due to chance and the secondary end point had a 1.75 in 100 chance of the improvements in drug arm being due to chance.
Also "The clinical effect was complemented by two independent biomarkers: A significant reduction in pathological amyloid beta levels in plasma1, as well as a significant slowing in the rate of pathological brain atrophy2 on MRI (Magnetic Resonance Imaging)3 scans.".
The reduction in brain volume reduction found via MRI had a 5 in 10,000 (or 1 in 2,000) chance of the improvements being due to chance.
Dr Jin was in charge for all these figures and he has over 20 years experience with FDA considering and analyzing alzherimers trials.
Imo as there is a lot of evidence that the drug is safe and the alternative approved drugs are fairly poor, even if the co-primary end point whch we don't know yet was not met at all these results are good enough that the drug should be approved.
They prob would have diluted before RETT Excellence announcement when stock was hovering around $10 if they were worried about the cash.
What do you mean not well balanced...we've been told in fairly quick succession that they look forward to "presenting in an upcoming major publication" the full data set so it's seems very likely it's happening and it could come out any time. It has been mentioned numerous times over the last 3 months unlike the PD data which I believed was mentioned once as planned to be peer reviewed that the bears keep mentioning.
We know from Sept pr they likely met 2 key end points with low p values under 0.025 in a trial with low screening/exlusion and a brain volume reduction loss with p =0.0005 or 5 in 10,000 chance that the improvements in the drug arm were due to chance. Even if one end point was missed imo the others should be enough.
These figures were all provided by Dr Kun Jin who has 20 odd years at FDA with his speciality literally being alzhimers drug trials.
What if someone sells or shorts on the back of your post and then the peer review journal is posted tomorrow and there is a giant sp increase? You equally could be doing real, material financial harm if these things do happen. Think about it.
If it's up a penny in 3 years then you can equally go long on it with impunity on ANY little fall.
Lol Doc, as I said unless you can see every company in that sample and view the bear and bull points on them and whether approved then the approval rate as we know is 85% and that pointing out only the bull or bear points on anavex isn't relevant without seeing whole sample.
Your response seemed to be to write out a large ananolgy where you again only pointed out the bearish aspects on Anavex and not bull (again seemingly ignoring that all companies in the sample including those approved would have had bearish points).