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theorysuit, you can continue to argue all you want but if your arguments are not logical, are obviously and easily disproven by Dr LL herself, or if you just post nonsensical, unsupported comments, you are better off finding other uses of your time and all board readers' time.
GLTA
theorysuit, there is a lot of noise here but it is not regarding the amazing scientific advancement being highlighted by the Nature article which NWBO is ushering to market, but, rather the noisemakers who continue to try to influence investors with useless and obviously incorrect statements such as yours about how oncology medical science is developed and practiced.
As has been confirmed many times the vaccine used by Dr LL is DCVax-L and this P2 study has tremendous positive supportive development effect on the DCVax platform short and longer term!
GLTA
learningcurve2020, there is no need to talk about unnecessary trials.
It is clear to improve on the survival performance of DCVax-L the immediate future pathway will be to focus on trials with studied and medically proven combo therapies and adjuvants. The elimination of chemo agents will be a tremendously valuable by-product of this platform development strategy. It is criminal to cancer suffering patients that the last few years has not resulted in more concurrent DCVax-L platform development because the funding has been criminally throttled.
This breakthrough in medical science will be broadly healthcare appreciated once the current combo trial is featured and used in practice, after DCVax-L approval. It will lead to accelerated adoption by physicians and broadening of dendritic cell cancer vaccine therapy, especially development of DCVax Direct. Any therapy that can affect lethal GBM the way the combo trial is demonstrating will be the most valuable medical breakthrough since vaccines were invented.
The pathway has no need for what you propose.
GLTA
hyperopia, thx, all correct in my opinion. Though I never cease to be concurrently amazed by what tiny NWBO has undertaken and yet disappointed at the length of time it takes them, they have arrived at the doorstep of something big and wonderful for the field of oncology. They will have to launch with mfg contsraints given the length of time the conventional aseptic mfg process takes but they will not be constrained for long as you discuss. Once Flaskworks is approved the sky is the limit to their capabilities as Flaskworks is scalable like very few mfg processes before it.
As with every step here there will be false shade thrown by professionally inexperienced posters whose sole experience is on posting boards. The change control process in this case is straight forward, the new process mimics the old process, only more sealed and automated, so the risk evaluation is considered relatively low and the resultant comparability studies are commensurate with the risk level. Still a lot of parameters to study but a relatively low risk compared to significant process changes. I know you know all this so I just include it for general use.
GLTA
antihama, you are correct, each step in the storage, transportation and administration process is specified by temp ranges and allowable excursion times, all studied and proven under strict protocols to ensure product quality from initial mfg to patient use. This is standard operating procedure for the industry.
StonkMaster, thx for the tracker. I will remain hopeful the RFI period is not necessary due to the 'Promising Innovative Medicine' status which provides for a closer relationship between therapy developer and MHRA during the development timeline, which allows MHRA to provide inputs into the development activities.
Additionally the benign safety profile helps to alleviate a significant deeply intense scouring for medical flags and potential causal links. There is still a significant medical review but I believe the depth of tangential potentials is greatly minimized given the large patient population to draw safety data from. Hopefully MHRA achieves what they set out to achieve with DCVax receiving the first PIM designation and hopefully NWBO took well advantage of what it offers and now benefits from this.
This sounds like just a lot of hope but it is just hope that things work out as planned by MHRA, nothing more.
GLTA
ccie1024, very good, you can see how easy the phony side of this really is, always hard work to build and so easy to tear down, sorry if I spun a negative on your new potential career path. Humor is so important in life, and, you are off to a great start though. Thx for this.
GLTA
flipper44, thx so much, again, you have been performing keen DD vs competitors for quite some time here, very helpful to investors here.
GLTA, exciting first approval on the near term horizon
Chiugray, thx for your insights. Great points, I also believe the benign safety profile of the DCVax platform opens up off label and indication expansion much more rapidly for sure. A couple of old axioms in business development for sale of product valuations were 10x EBITDA for existing products and 3x peak sales for new products. The new product one is particularly rough and needs considerable market and product insights to be useful. The key is to reasonably project peak sales which are heavily contingent upon IP strength. Regarding the DCVax platform, there is so much to be answered about development timing due to the slowed timeline over the last few years but the high sales potential is obviously positive to the longer term members here, probably more members here. The IP strength may be a challenge and may rest heavily upon the mfg process protection. I think in order to capitalize on the platform NWBO needs to partner quickly to kick up their clinical program to support their patent claims across oncology indications.
Valuing a technology such as DCVax is quite difficult, but it is easy to get into significant numbers of billions to several billions of annual sales in the mid term horizon and the market may pull them along rapidly. I am not too sure they will ever be able to fully capitalize on the real long term valuation potential due to the timeline they have experienced and it will take a strong partner to help maximize valuation, which I believe they will find, Merck may be the best fit.
Merck is a top notch BP company with a decades long proven track record of monetizable medical science and deserve a strong multiple of sales valuation.
It is very exciting to see NWBO at this stage with its flagship approval on the near term horizon! There is no doubt there will be additional oncology indications addressed both on and off label in ensuing years here post 2024 and rapid platform expansion should occur. Once the first approval is granted the challenge of valuing NWBO becomes a real challenge for the market and I think it will be up to LP to define reasonable financial goals while pursuing what in the past have been considered unreasonable growth projections even for a pharma product. I have seen companies under estimate growth potential and it can actually be ugly. I have seen companies have an internal and an external growth projection for various reasons, which I think will happen here with internal being higher. The market will take DCVax to task and NWBO will need to be up to the task. The required mfg footprint and investment is easily scaled due to Flaskworks, it may be the rest of the company's mgmt processes which prove to be their larger challenge which a partner can resolve.
GLTA , exciting times on the near term horizon
Doc logic, the only way I see this going down is a strategic partnership initially. There is no sound risk based way to value L yet let alone Direct as a platform, too many assumptions and too high a risk, particularly where the IP is not a traditional set. I think there will be a licensing of L first for GBM commercialization and for L development followed by a licensing for Direct development. BP's can only assume so much portfolio risk and while DCVax appears quite promising in the oncology grand picture I think there is a need to validate further and a partnership will provide that time and opportunity. This is where the corrupt MM's and related parties should be held accountable in my opinion. NWBO could have already had 5 yrs of platform development across cancer indications for both L and Direct if not for the horrible financial manipulation and I believe they would already have been in a partnership or two along the way.
Merck is one of the better research based BP's as opposed to say Pfizer, which is a keenly financially based BP. Merck would be a great partner for NWBO for several reasons and their new construction may or may not be related, it does seem coincidental for sure, though Merck has its vaccine hands in several areas and if they mfg their pneumococcal vaccine at West Point Pa it is a footprint consuming process given the high number of valents required. Given the fact that the FDA submission is not yet made and the approval will probably require at least 10 mos the first production for USA should be around Jan 2025 at best, which given such construction and qualification timelines appears about right. When you hear dates for pharma site completion it may be up to another year for site qualification activities.
GLTA
There are 2 concurrent event paths occurring here and it is not the first time but it would be great to see via a court case win for NWBO that it is the last. The first event path is the timeline toward approval which is moving ahead fine with little reason to doubt imminent approval. The other event path is the market valuation which is controlled by the corrupt and illegal market manipulators. There is little connection between the two here at NWBO investor land other than NWBO has had to issue many more shares than it should have had to in order to make the progress they have made. At this stage the market cap, which is the real valuation of any company, is under valued and it will take a few financial related steps to remedy that event path.
I keep reminding myself they have filed for both nGBM and rGBM, quite a notch higher in market value than originally foreseen as only filing for nGBM.
GLTA
hyperopia, I think you know it is only a superficial step in the review process whether to accept, give receipt for transmission or to validate a submission. Giving receipt only means the submission was successfully electronically transmitted. Accepting or validating only means the submission appear to have all the required sections. Only the review process will determine the quality of the submission and if anything is left to question the question will be asked and if it is a major question it typically will delay the review or cause the submission to be rejected and the sponsor will need to start over.
Anyone waiting for a submission to be approved has to understand nothing is guaranteed until approval. Typically when labeling discussions are initiated, which is late in the process, the submission is headed for approval imminently though labeling negotiations can still cause a delay but typically do not as the sponsor company will present its case and accept the RA decision at that point.
So, all in, whenever a negative is not conveyed by the sponsor it means all is good. I think NWBO has had sufficient time and access to MHRA contacts to ensure a high quality and complete submission and I am sure they employed MHRA experienced consultants to prepare it. I believe they will do whatever continues to maintain their MHRA relationship including following their wishes for no extra communication steps during review.
GLTA , I look forward to next PR about ASM and submission and believe the last 3 yrs was quality work by NWBO
hyperopia, I also agree with you and sentiment stocks and look forward to the next PR concerning the submission, it should be positively noteworthy. A little of optimism keeps me patient so I employ it, but at this time I think this is actually quite accurate.
GLTA
sentiment stocks, it is just logical to me that if the first DCVax filing was with FDA the submission acceptance step would be PR'd due to the review process in the USA highlighting that step but since the first filing was in the UK and the MHRA frowns on PR'ng this step NWBO will not do anything that wrinkles their MHRA relationship nor should they. All is good with the review process unless NWBO says otherwise and given their drug development status of PIM in the UK they have had the ability to significant discussions to ensure a complete filing.
GLTA
Horseb4CarT, I agree, NWBO is not in business to expend their resources to change the corruption of the Wall St market maker function and will accept an appropriate settlement, but that settlement will hopefully be a very strong precedent for all others to follow including the SEC which will close the door on this chapter of Wall St corruption.
It will be difficult for the MM's to reinvent themselves and their business model. They started out with a defined need which still exists and if they are smart they will fall back in line and seek replacement value added services to increase market efficiency. Maybe just the corrupt ones drop out.
This will also negatively affect the career path of paid bashing, which is already jeopardized by AI.
GLTA
merluc, most of us here understand the huge benefits of the Eden system in the DCVax-L mfg train and I agree with you the most logical reasoning for the MAA delay is it's inclusion. Whilst the small company resource level is a fraction of the BP's and a few other technical sections of a BLA/MAA can pose a challenge to them, 3+ years from datalock to submission in my mind, including the final delay, is a signal Eden is most likely included as concurrent development of this instrumental mfg device alongside the management of the closure, analysis and publication of the study allows for an appropriate development timeline.
The development and validation of the Eden system would have been the most complex undertaking in that period of time and would have consumed mostly different technical resources during this time. I am hopeful for a positive surprise or two coming starting with a shortened approval period, though I am aware of the risks of aggressive expectations here and the Eden system development may wind up the largest focal point of the MAA review. From what I see LP has been very deliberate, inclusive and patient in her pathway to this point and it is logical to me her pathway has included the Eden system. And I agree the Eden system inventor would not remain post completion of the development activity as I believe he is not a pharma mgmt person but an inventor.
GLTA
John Bull, please explain your take on the science of DCVax-L in simple terms and include your commentary on the JAMA article rather than only focusing only on the financials. Ruining the financials of companies has been the focus of entities who regularly employ tactics on many companies via the use of legal/illegal tools. Typically the big 3 issues on any company, particularly a biotech. are science, financing and leadership and the easiest for shorting entities to attack and point to is the financing. Your take on the science is welcome.
GLTA
Gary,
I think the major hurdle to bring back pharma mfg to the states for critical generic products is the pharma business model. Obviously the safest place to have critical products made is in the states due to potential logistical and geopolitical obstacles are we are seeing today in the Red Sea, especially understanding the main reason to outsource any of this mfg is cost and where those locations would be. I think it is possible to re-engineer the business model to be successful here but it would take leadership, coordination and collaboration between the industry and govt with all the work done by the pharma industry.
The work done with building materials is an absolute necessity for alternative power systems because the real estate does not exist for wind and solar on land. There is work to be done with holistic studies and pilot projects if we could only understand how not to waste significant resources along the way by moving incorrectly. I will leave the study of the science behind all of the urgency backdrop out of the conversation but for anyone interested it is a fascinating study to take on. I recently costed out solar for my home and decided the expense was still way too high for the benefit, and the grids will need work to support EV's unless home systems are also installed. Building solar into new homes is the way to pilot them, though duality of systems will still be required in most climate zones. I only know 1 person who has an EV and he bought it as a 'toy' as he is retired and thinks it will benefit society so he and his wife have 3 cars, one being an EV.
I hope to see the old pharma industry make a comeback in the mfg end of the business with all critical API and finished dosage forms made in the USA again. The volume is huge and the high quality jobs would be a large boon to the economy, even considering it would be heavily automated.
GLTA , DCVax will definitely benefit society!
flipper44, as usual I think your questioning is informed and spot on. There are times to call NWBO (DInnes) to let them know many retail investors are questioning their actions or timelines and I think this is one such time. The company is on the brink of transitioning to a commercial entity and there are several key questions around that transition. But, the timing and pathway to that end is what we all seek.
The MHRA process vs the FDA process is somewhat front loaded, meaning there is more meetings and work expected of the sponsoring company prior to submission, thereby allowing less time required for review, though the potential break at halfway allows for flex as needed on the part of the reviewers. To me this means there is less potential for delay problems and more potential for successful submissions, resulting in the 80 day figure I think you unearthed. I could not find MHRA listings of in-process reviews by MHRA as FDA publishes, which would be logical to me as they do not have as firm committed end dates but rather time ranges for review completion. If true, it also implies to me they are less open about their in-process work.
This submission is for a very complex disease but the therapy is biologically straight forward and based on medical science whose foundation is not new. And, when one recalls the primary concern for all therapies is patient safety, this review has been further simplified. In addition this work has been published and there now exists a depth of supporting scientific publications. All in, this review process appears to be a CMC and an efficacy statistical review focused one, relatively finite sections in the BLA. I say all this because, though every time we think NWBO is engaged in a time saving endeavor they wind up taking a beneficial but longer route, I think it is quite possible the hold for the ASM announcement is to hit a review milestone, and it is not outside the realm of possibility of the hold potentially being for approval, given the review method employed by MHRA and the existence of so many supporting factors of the severity of GBM and the UK's actions to enable more rapid reviews. The only reason why DCVax-L may not be given every time advantage could be the level of organization behind it not being ready for prime time.
Nothing new in what I said above, you are well aware of this. I only say this to advise all here who are truly interested in the success of DCVax-L to take the time to contact DInnes to ask for their timeline, their approval pathway and their commercialization plans, which should all be explained in the ASM.
One can also think the hold on the ASM could be due to their final step here, the commercialization plans, which is the logical immediate follow on question to the regulatory approval pathway and timing. They very well may already know the pathway and the projected timing and may be working with MHRA to keep a lid on them, so they may be focused on their commercialization plans, which of course includes their mfg readiness and implementation timing for Flaskworks. There is much for them to do in a short period of time with modest resources. They are best positioned in the UK but still have work to do there, while there is much more to do in most other markets. This is a very active time in their offices.
As always we are left somewhat info handicapped but it may be mostly due to their short pathway now, for the first time, actually being shorter than longer. I will hope this is the case and will also contact them to ascertain what I can about these next steps which are not all current regulatory secrets.
GLTA
Doc logic, well said, I am hopeful the scientific community may be able to lead the way toward reversal of the apparent societal acceptance of corruption in all types of organizations mostly caused by the massive sums of money involved and apparent deterioration of societal ethical norms. NWBO has a story that touches on several seriously corrupt issues at the expense of cancer patients primarily and investors. Since science should not be influenced by corruption but built upon the openly challenged scientific method and medical science improves the lives of all and should therefore be supported by all, maybe showing this story will start the ethics rejuvination. I strive for optimism regarding the goodness of mankind.
LP is to be commended, though I still want more communication to shareholders. Now I am wondering why no ASM is yet scheduled but I am sure that wondering will soon be answered as have past wonderings.
GLTA
sentiment stocks, thx so much for this work done on the court case, extremely helpful to understanding its real status
GLTA
pgsd, I have to say this is another potential benefit of the NWBO mgmt taking the slow (OS, Flaskworks) road to submission, which may gain time in the end.
When one considers the large body of benign safety data and a baseline efficacy which has potential for much more in combo therapy which is already in the clinic, and assumed manufacturing readiness the review process feels good. Next up is a launch ready organization.
GLTA
dstock07734, you raise a valid point and as soon as we see verification of all the people receiving the therapeutic benefits of the treatment we will all feel better as well. God Bless Les but he does tend to inflate some of his statements. Surely you can understand all of us who have been here since what feels like the days of Moses just need to be able to verify the timeline is continuing to progress. In the case of the submission validation we just needed to verify the 150 day clock started.
Thx for all your posts and the compassionate care usage will turn out to be a key supporting element of the eventual DCVax-L approval in less than 150 days.
GLTA
IrishMc67, a lot there and all well said!
GLTA
flipper44, thx for this link to clarify.
This is a difference between FDA and MHRA processes. MHRA relies more on pre-submission meetings and their shared checklist while FDA takes more time, up to 2 mos, to review an application for acceptance, but that time in FDA counts against the review timeline. MHRA validates for content completeness concurrent with electronic transmission receipt while FDA has a separate step. And this includes the regulatory pathway discussed in pre-submission meetings with MHRA as well as the review timing. Good to know, NWBO keeps their PR's to the point expecting shareholders to understand more than they should expect IMO. Now we know they are on the 150 day timeline starting when MHRA signaled acceptance of their submission.
I wonder now what they are waiting for to announce the ASM?
GLTA
Awful experience, great that you survived it. I don't like the rot in our large govt systems such as our medical system, which is one that jeopardizes everyone if not conducted well, as you experienced. I hope some day we can achieve a continual improvement mindset of sound and active system monitoring over our medical system which can address high costs and insufficient care in many cases. I saw the extent companies go to reporting adverse events and side effects of marketed drugs and FDA cannot properly monitor and utilize this mountain of data, though there are significant learnings buried there. And the learnings can be applied to research of new therapies as well. Every area of medical research and practice could be advanced more intelligently and in more integrated fashion, AI may help but we do not have to wait for nor rely on that. As time goes by we see that any system that does not continue to progress and improve will start to decay, especially as size and monetary flows grow. Thx for sharing and great you survived but awful that you experienced it.
Neuro-degenerative diseases are like using Ancestry.com, the further you go back the complexity is geometric. Each stage causes the next successive stage so you could say each stage is causative of the next stage. Ultimately these diseases may be deeply understood as to what causes the first stage of degeneration but there may be simple answers in some cases like old age, yet more complex answers in others like genetic disposition and/or other related triggers. I suspect we are still decades away from connecting all the dots, and even when we do, the approach to managing the disease may not be to address the first stage but to address a stage which we can affect more efficiently.
This is a complex space with so much work to do, with advances coming mostly through the set of small companies with good researchers who continue to progress. The ANVS approach is another fascinating one in a space desperately in need of solid progress toward effective treatment, even if not yet addressing the initial root cause stage.
Jan readout will determine if this approach is progress or not, I am bullish as I am with other small companies advancing this field, like all people I have seen people affected by these terrible diseases. My observation is this company has a well done body of research behind its approach though as with all small companies the depth is limited, especially the clinical data, with only the 54 patient PD data providing data strength. But all is aligned from compound design to clinical data so hopefully real progress will be made.
GLTA
Best wishes Smokey21 for all the strength and healing you need, God Bless you!
GO NWBO!
antihama, thx, organizations I was in gave me the opportunity to participate on Part XI teams and we focused on the basics of data security, both physical and digital, then systems validation and tried to avoid the malaise created when the depths of the software metadata were being philosophically discussed as it tended to thwart progress. I found auditors very open to what we did, quite helpful as we partnered to gain benefit from the efforts, and we all saw the benefits of better control over our data and systems, even in and sometimes especially in the labs.
Our Part XI challenges pale to what our friends in NWBO and Sawston,... are tackling today I must say.
GLTA
Doc logic, so spot on, thx. I hope the readers of boards like this can use their wisdom and experience to determine the posters who post with integrity and facts vs the others. It may take time for posters to make those determinations but it will be time well spent for them. NWBO has such a fascinating medical breakthrough that needs to get to market asap because it will be foundational to future tiers of medical science. Posters like you are the beacons for people here and 2024, though back in 2016 or 2018 or 2020 I would not have envisioned the number 2024, will show that and people will be grateful to you and others here. God bless all here, NWBO's efforts to multi-task, and, the patients who will benefit from this technology in the future, which will be many.
GLTA
Horseb4CarT, thx, absolutely agree, so much to reflect on here, my perspective is for all our grandkids, but this board is a focused subject and NWBO winning their lawsuit, though not their main thrust, can serve a small victory for integrity. It is truly hard to comprehend how our markets have been allowed to become so corrupted, and it is not the only major example. The road back will be very hard, but, making public the depth of the issue is the first step. I don't think market corruption should have been left to NWBO, but, here it is and here we are. Let's go NWBO, bring DCVax-L approval to market in 2024 and show the country the deep corruption that has been allowed to thrive and prosper in our stock markets. All, IMO, thx again.
GLTA
Hear, Hear, just a matter of time and strength of faith.
ae justerer, unbelievable we have allowed things to be so deeply corrupted but I suppose this is what happens to societies that are successful if not kept in check though there was supposed to be layers of govt oversight to keep us on the straight and narrow. Money is hard to keep in check and big money is so much harder, history has shown us that. Govt has to be cleaned up and it matters none whether from the bottom up or the top down but the top down tends to work faster. Hoffmann stands to be thanked and congratulated along with NWBO here. This is truly too much for a tiny biotech to undertake, but NWBO is doing it, albeit slower than we would like. It is an amazing effort on their part and victory is so close!
GLTA
BrightBoy, thx much for your posts and I have to say I love what Hoffman is doing, his legal insights and breakdowns are just wonderful.
GLTA
Marzan, unfortunately we are reverting some to a wild west where ethical controls were left more to individuals. We are tasked now to rely less on systems and reputations and more on ourselves to develop and use sound judgement on info sources to determine truth. It has become more complicated in the information age and stands to become more complicated as we move forward in a world more driven more and more by financial incentives. Pres Reagan said it well with "trust but verify" and I think Dr Deming said it best with "in God we trust, all else bring data". Wisdom is at a premium, probably always was and always will be.
CaptainObvious, I went through Y2K with mfg plants and though we would never admit it to our IT teams, we knew in pharma all mfg control equipment had to be assured to function properly and without accompanying data you have no product, so all systems had to function correctly incl all system connections. The spend was well worth it to check and update systems as needed. Then came Part XI if you had the fun experience to be involved in that one too. I worked with some good IT folks through all that. We knew there was high risk except in one building we still had 75+ year old electrical relay operated elevators that contained no software.
GermanCol, thanks much, I appreciate your analytical posts which show a sound understanding of the stats. It is so refreshing to see, as is often the case on this board from several posters, sound analysis based on the facts and data. Those of us who have been here for several to many years have lived through this noise on boards and in the market in general, no ethics, complete lawlessness as the lawsuit will show. Thanks again for combatting the trashy noise of baseless posters with real analysis. Hopefully we will see the proof shortly with submissions and approvals starting within weeks.
GLTA
The CEO is very openly bullish and since she is a lead researcher of the compound she has some credibility. In the past it has not been wise for a CEO to speak so openly about anecdotal responses but in this market place with such financial pressure by shorters there needs to be some tools or tactics for CEO's to use to support a fair valuation of their shares.
This is a fascinating compound, from its design to its MOA to its recent P2 data, though limited in volume. I place some weight on the 54 PD patients data since it is a reasonable mid size sample size to attain a starting point for stats. I don't think I have ever seen such a strong stat performance from such a small sample population, which is eye opening. The observations of rapid enrollment and low drop out rates in both trials are indicative of trial physician support and at least patient safety success.
The contradiction here is that the MOA is superbly simplistic and holistic as far as neurodegeneration is concerned but the logic of its approach gives one the initial impression that there is no way Big Pharma could have missed this approach. But BP can be blinded at times and it takes years to decades to modify their approach. This approach seems too simple, but this would not be the first such example of a simpler approach being correct since the scientific achievement is in finding how to make the simpler approach a reality. This compound's MOA helps to explain why there have been other single degenerative protein approaches which have demonstrated limited temporary success only to completely succumb in the longer term as only one degenerative protein is being controlled by the other compounds while the other degenerative proteins continue to agglomerate in the brain. This means there exists synergy between the decades long BP approaches and this one.
The alignment of all the preclinical through early to mid clinical data is consistent but in the field of neuro there are hurdles of proof in cognitive testing, which is why Parkinsons mobility is a great complement to evaluate concurrently with AD cognition. I see this as an interesting SWAG at this stage as there is compelling data but not a lot of it, otherwise the company would already be in the billions. Not many small companies, though I know of one in oncology, can offer such potential value. This compound, like the other company I reference could bring medical science revolution to the market. The benefit this company has is a shorter development timeline than the other company, more traditional trial metrics, and it has not garnered the destructive attention of large shorting entities. The timeline here now does not allow for large shorting games and the potential upside value is too significant of a risk given the low float.
All in all this is still a binary investment situation but there is a strong positive case for a potentially successful outcome in a medical field where all have failed to date, except a few very limited successes. Patenting the newly developed crystalline form of the compound for IP purposes in addition to added stability is a positive. I think, given the safety profile that will be available and the proof of the MOA post both the PD and AD trials in coming months if both trials are successful, the FDA will be receptive to an accelerated approval pathway, at least that would be logical and patient serving though it is possible there may be additional P3's in both indications required, strength of results may be the determining factor.
GLTA
hoffmann6383, I could give a lengthy thanks but will just say THANK YOU very much for your work here!!!
Lykiri, thx
GLTA