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exwannabe,
There was probably only a very narrow window of time when DCVax-Prostrate would have had some serious attention from anyone. Big pharma didn't like the business model chances for success let alone limited benefit seen to begin with. Then when Provenge was approved up until DNDN bankruptcy the challenges became obvious even if better management could have made it profitable to a limited extent. During this time frame DCVax-L might have had some interest shown simply because they had a better process in place to control cost of goods sold. The main problem for NWBO would have been they never had enough money in the coffers to partner with good terms so the study would have been nearly completely in the hands of a partner if there was an offer of some sort actually made. That offer, if ever made, may have included rights to additional indications for the base DCVax technology as well. Too much guessing here, I know, but that is generally how it works with a cash strapped company.
Pyrrhonian,
Cellular therapy became a national priority in Great Britain when the DCVax-L trial became designated as such. Since that time, government funding there has begun to be used to increase cellular therapy production capacity with the building of new facilities. Granted the multipurpose nature does not directly tie in to NWBO but the fact that their readiness seems to be coinciding with Phase 3 completion should not be overlooked. Most other cellular therapies are many years away from commercial production launch let alone capacity and would need others to fill the gaps for them in a fairly big way if and when they do come online. Even those who do have nearer term anticipated production runs are expecting very low quantities compared to what most investor expectations have been. Why? NWBO, through Cognate, does not have the same expected wait time for ramp up so with Great Britain bringing capacity on line fairly quickly we need to be thinking about why there is an obvious priority based need for this right now especially when others seem to have their low expectation runs already covered.
flipper44,
There is that September thing again and wasn't the EAP where those missing pseudo progressors that sentiment stocks was talking about ended up? Crazy huh? Kind of seems like investigations, trial readouts and manufacturing news could be like about 7 arrows all pointed at the same target and being released so they hit at about the same time. Let's see what they come up with to deal the August payment needs. Best wishes.
AVII77,
Thank you for the time you took to respond. Much appreciated. Best wishes.
doingmybest,
Thanks for the input. Your shared experience is a valuable source of information with regard to the potential reasons for delayed announcements. Best wishes.
Pyrrhonian,
Your numbers need to start with your base average cost between various DC manufacturers and then add in the cost of developing, implementing and validating, through regulatory approvals, the cost of automation for 2 different cellular products on multiple continents and at least 4 separate sites. That might run the cost up a bit right? Then add in the cost of proof of ability to ramp up to expected commercial production levels to meet anticipated demand estimated not only by the company but also by regulators that is necessary for receiving BLA approval. Mo money right? Keeping it all confidential.. priceless. Both the pre-revelation stock price and the potential the revelation holds. One looks like a zero the other like a 1 with multiple zeros behind it. Conviction is a funny atribute because it is often confused with stubbornness. What you are convinced of I am not. If I was convinced as you are about your concerns then my actions would be stubbornly foolish and stubborn would be a justifiable tag line for me. For the time being I stand on my convoctions. Best wishes.
Pyrrhonian,
First of all I agree that FDA would not cause a temporary halt of a trial just because commercial scale manufacturing was not in place. That would be an issue only if a BLA was in place and the company was waiting on a response which would include a review of manufacturing preparedness. The question about the temporary screening suspension had to do with another issue then unless we know for a fact that a BLA is in place. The problem is we don't know for a fact that a rolling BLA is not in place since FDA keeps requesting additional information.
The real wild card here is how the pseudo progressor trial might fit into everything. Something was changed there very quietly and without any fanfair which is highly uncharacteristic for NWBO according to the bears aND many longs wold also agree. We know that they were going to be added into the Phase 3 results if the Phase 3 could pass muster on its own. Are we waiting on trending results from the Phase 3 to do this and response from a petition to use these combined results without finishing the planned enrollment? This may not involve a BLA if the pseudo trial was halted for positive ethical reasons but then again it might right?
Another point about early vs late tratment data being uniterpretable is pure speculation on your part. If later patients are doing better than earlier ones they would dig to find out why not condemn the trial. Best wishes.
Pyrrhonian,
Are you saying that a BLA won't receive a CRL if an approved, scalable model for commercialization is not in place on time? That is not how I understand their final approval proess.
flipper44,
That theory is a good theory for the positive outcome that aligns with the pseudo trial activity, the comments by Dr. Prins and Dr. Liau and the obvious build out of manufacturing. This is more than balanced out right now because of the current NWBO financial condition irregardless of cause, the silence irregardless of cause and past history of missed deadlines. For many this represents more than sufficient evidence that a positive near term outcome can not be achieved. Those who have been warning of this danger, whether eventually proven right or wrong about specifics, have been right to warn about the price direction. Buyer beware is a very necessary message no matter the source especially in this sector. With this said, I still believe the positives mentioned at the top of this post will have enough time to play out and I still plan to add to my position between now and the end of this year as timing and circumstances dictate and or allow. Best wishes.
I meant minority partner with Cognate or Toucan for a large equity stake. I'm not saying they would need to do this but the option is always there which helped me see a way that the investment could be derisked to some degree and NWBO stock value could be at least temporarily manipulated by the company with financing news generated on favorable terms for all investors. Without commercial manufacturing build out this would have been a longer term loosing proposition. At this point it makes much more sense.
maverick 1,
Happy 4th to you as well and thanks for posting. There is something Linda and Toucan can do to raise equity which they don't want to do but could and that is to take on a minority partner for a large equity stake. This is another leverage point they can use to avoid drastic measures and improve the value of their stock in NWBO,
Pip11,
Reality check-The cards are not all on the table and many longs are in until they are. Remember Rocky Balboa or JAZZ or the Miami Heat and San Antonio Spurs playoffs or much more recently the Cleveland Cavaliers? Maybe you better think twice about what that pseudo trial means. Best wishes.
exwannabe,
Strange as it may seem the charts were posted by Pyrrhonian on ihub a while back comparing DC vaccination alone to DC plus check point inhibitors. The big pharma report was released last year I believe. I'll try to find it for you later from my notes. Happy 4th of July to you.
exwannabe,
I thought you were made keenly aware by sentiment stocks that the pseudo progressors were obviously dealt with by quiet regulator intervention after they saw what Dr. Prins and Dr. Liau were talking about with regard to the mesenchymal subset and mesenchymal phenotype transitioning that might have something to do with the whole Phase 3 trial group of patients living longer. Could they be waiting on entire group statistical significance what with so many late entries, delayed PFS in the treatment arm and all. That would kind of keep everything about those trials on the down low right? Remember, it was big pharma research that proved DC vaccines improved patient outcomes for those given their checkpoint inhibitors. FDA can't disregard this third party evidence because it's already in the books.
Pyrrhonian,
I have not solved the mystery but others appear to be coming very close to doing so for many types of cancer based on the tools they have access to. Highly conserved protein signaling pathways are important targets and NWBO is not the only company that has been working with those that are most critical. . AVII would recognize the importance of finding these type of targets from the research that AVII the company had been working on with regard to a universal A+B type flu vaccine using conserved and de novo targets. I have simply been watching from a distance while others have been in the laboratory for over 20 years. The number of key targets that researchers are honing in on is becoming much more focused and as Dr. Prins indicated, DC vaccines are able to help activate and then identify T-cells that have determined which targets are the most critical. This is not a pipe dream as you suggest but rather the beginning of a payoff from decades of research. The new NWBO scientific advisory board will have their hands full.
sentiment stocks,
Alas, time is a gift that in it's course reveals the hidden truth.. wherein human weakness lies and evil is brought to judgment except where grace abounds. Best wishes.
exwannabe,
I may have read something wrong but I believe the environmental remediation issue is not considered pressing or relevant to the current construction activity or manufacturing readiness. It is an issue that must be dealt with in an ongoing basis under the ownership. I have not read or do not remember reading anywhere where a final decision was made with regard to projected costs and final remediation deadline.
iclight,
Just call the refrigerator delivery guy. He could tell you.LOL
Pyrrhonian,
We are closer than you think. If you understood the value of CXCR4 and a few other key receptor sites and their ligands you would know this. You led me to do extensive research in this area when you were posting about another company with a product in trials that helped repair and prevent additional heart muscle damage in ischemic areas after a heart attack. Once I realized how CXCR4 levels are regulated by certain gene sensitivity to oxygen levels things started to make more sense. CXCR4 is found on a wide variety of cells including certain very important subsets of cells. Some of the cells are able to act and react in such a way as to modify cellular behavior and or characteristics. The new scientific advisory board will, I'm sure, be sorting through a great deal of information fairly soon about the best next steps for implementation of existing technology but also, to some extent at least by a few, the direction of future research.
In my opinion many of the big biopharmas still have a great deal of pain in front of them but the offset for some of them is that many of the promising small bios can now be bought cheap during the great rebalancing that started a while back in anticipation of upcoming events.
Adam,
I thought we were all in agreement that NWBO is not a 'Normal' company. "Peculiar", "Intiguing", "Mysterious" or "Eccentric" seems much more appropriate. Much appreciated "Game Changer" might be what sticks though. Even for those who consider themselves experts there is only one time when its too late to learn and that time for you has not yet arrived. Best wishes.
Pyrrhonian,
It's not the 32 that might be added back in to the main trial but what happened to the others planned for in that small group that never made it in and went elsewhere. That is the elephant in the room. LOL.
eagle8,
That's "elementary Watson".
Pyrrhonian,
In your entire post only one mean measurement of 1.9 months PFS benefit is discussed. Your post makes sense when discussing those types of numbers. NWBO is looking for a minimum difference of 4 months. At that point the doubts become mute as does your argument. The fact that a separate trial for pseudos can be used to confirm what is happening in the main trial adds an elephant's worth of weight to the main trial. Best wishes.
flipper44,
Reminds me of an old song.. "Do you remember the days of September..?" Somehow I think we will remember will.
Rkmatters,
Better to be blessed than good but both is even better. I am consistently reminded of this and have to smile when I watch a good strategy get decimated by someone who, on any given night, might consistently beat the odds by picking needle dominoes out of the proverbial haystack.
Pyrrhonian,
You know as well as anyone that the specific (not general) activation and maturation is all important. Unless you get the right type of activation response will be limited due to the suppressive nature of immune response by cancer. The fact that NWBO has been more methodical and has a longer connection to DC studies than just about anyone else has kept them in the game while others have steadily shown how easy it is to fall short. There is no comparison because these DCs are not generic they are specifically engaged and activated unlike all others tested to date. Best wishes.
Rkmatters,
TPIV is one I have had on my watch list since before you first started mentioning it because of it's MO and relationship to Mayo Clinic. You have a good eye for potential.
md1225,
I think "Adam" missed sentiment stocks recent "aha moment" post.
exwannabe,
Two things to consider from your post. The first is that you said you believe that the blinded pseudo trial can help with full approval for the main trial. The second is that there are 2 types of pseudo progressors.
With regard to your first point about the pseudo trial helping the main trial I agree. Not only can these results be added into a successful Phase 3 but this can also act as a balancing of subtypes to reflect a non biased patient population which is important to the expected outcome for the general GBM population. This is especially true if most or nearly all patients can benefit to varying degrees based on subtype or changed phenotype at progression with pseudo progressors being those likely to receive the best outcomes but others helped as well.
With regard to the second point about early and late pseudo progressors, the data will be stratified enough to demonstrate how the timing of pseudo progression as it relates to SOC radiation treatment alone vs late radiation response/DCVax response affects outcome. This is because early pseudo progressors would be mainly in the separate blinded study and any late pseudo progressors would be in the main Phase 3 trial. The data from these 2 sets of pseudo populations could be considered confirmatory for all pseudo progressors with enough confirmatory response rates could it not? How do you think this would relate to the old arguments about data mining for subgroup populations and alpha spend reserve built into the main trial? Something to think about. Best wishes.
exwannabe,
You seem intent on ignoring sentiment stocks post about the separate blinded pseudoprogessor trial with more mature data which would appear to be strongly supportive but apart from Phase 3 trial results. Can you please explain why?
antihama,
I do not disagree with your assessment that protocol may be something being looked at as well. I just think that once equipment is installed it will all need to test out to produce product as good as or better than the early patients received. Early vs late and not just treatment vs SOC to crossover. Best wishes.
Maverick 1,
Didn't Goldman Sachs recently receive a cease and desist order and a fine for not acting in accordance to regulations? UBS also had a recent court decision go against them as well if I recall correctly.
maverick 1
I like your assessment and believe Dennis would definately help. It just seems strange to me that the 2 companies recently implicated are both involved with NWBO and would not be cooperating by now with authorities.
DoGood DoWell,
The silence and recent court rulings also leads me to believe that a larger outside investigation may be involved. I hope NWBO hasn't hasn't been asked to remain silent with their own investigation and essentially be used as bait but I have not been able to rule out that possibility. Somebody big has been buying up shares lately which might be keeping NWBO from going bankrupt. This is just a crazy idea but what if these shares were actually being bought and set aside to keep the company from going bankrupt while an investigation is ongoing? Could UBS and others be cooperating with authorities since their own little fiascos resulted in slaps on the wrist for earlier evidence against them that may have led to a wider investigation? Hmmmm.
exwannabe,
This reasoning is one of the reasons I suggested a while back that a BLA for the Phase 3 had probably not been applied for. Linda's MO is to take everything one slow step at a time. What makes more sense to me is that the pseudo trial has been reviewed and a petition to include results into the main arm has been asked for but with eventing being so slow and late rapid enrollment, a determination of effectiveness has not yet been determined. Along with this the test for detetmiming patients most likely to respond, utilized by UCLA, may also be in the process of review with DCVax-L patients to date. Couple this with the manufacturing equivalency issues in preparation for commercial launch, the extensive and time consuming effort required to produce a BLA and Linda's promise not to apply for AA until the end of the trial and you have the makings of a methodical push forward with the march of time not on the side of favorable financing unless Linda does something unexpected. Ethically speaking, regulators will need to make some sort of determination on the pseudo progressors to allow them to get access to treatment if data is overwhelming enough. This decision may hinge on commercial quantity availability both in the US and Europe which is why I have said to keep an eye on manufacturing readiness. We can only hope that at least some patients (pseudos) will have the chance to benefit from this treatment soon. Best wishes.
sentiment stocks,
He knows he is wrong but likes getting under everyone's skin. Not to worry. To be wrong with NWBO is unthinkable as it would be the greatest failure to recognize the potential reality of a paradigm shift in cancer treatment imaginable. He would have to answer how anyone claiming to be a savy biotech blogger could be so blind. That is not a pleasant thought for what the future would then hold so NWBO success is not an option for him. Best wishes.
Rkmatters,
That would be the gold standard answer. Best wishes.
sentiment stocks,
I think TC Trader helped clear up some of the action when he said that the market maker appeared to be matching up buys and sells during the day which is what led to the low volume being reported for about 3 hours. TC Trader said he would need to check further about after hours trading but that during the day it was mainly UBS causing most of the activity. Whether institutions actually held the shares or could lend them out might depend on the actual rules governing where those shares could actually be held. I think maverick 1 was trying to make clear that the brokerages that actually hold retail shares are the ones that can lend them out when a margin account is used. This may also apply, but I am not sure, to institutions that purchase the shares with a margin account but have them held by other brokerages that then might lend them out if this is even possible, which I suppose would be contingent upon the governing rules. If this is possible then reports would show them as held by institutions when in fact the rights to recover them might be all they have because they were lent out by the brokerage, that was their holding agent, to be sold short by a third party. I hope TC Trader has time to bring some additional clarity to this and the after hours trading. Best wishes.
TC Trader,
Thank you for the post and flipper44 for the question posed to you. Best wishes on catching up.
maverick 1,
Might that second option you suggest draw some unwanted attention perhaps with regard to unusual trading activity?