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Depends what the price was at the time. If it was 200 and dropped to 198 I am sure you would not be too upset.
It took a bit longer than we all wanted, but now the clock is ticking. My guess is that since news tends to leak it is likely that the market will know some unofficial results before December. If you believe in the theory you better buy now before the stock begins to run.
Who is ready for some fun?
LOL, so you are privy to the exact reason he made the deal with ONCS or did not make the deal with INO? So what about the other reason?
DrL,
It seems like you are arguing that TILs play a major role in regulating if PD1/aPD1 will work. Thanks for the hard work tracking down the evidence that NOW in retrospect creates a coherent story. It strongly supports the work that ONCS is doing and provides credence to the theory they are testing. It seems like it is only a matter of time until ONCS stock explodes to the upside as more investors and funds put two and two together.
Thanks. I think I will go invest everything I own in ZGNX. I will sell my shares in ONCS first thing in the morning as your arguments have been very convincing. The data you use and logic is second to none. I almost based all of my decisions on the data of 4 patients. Thank you for saving me. I recommend that everyone should do the same and sell every share that they own. Do not buy any shares of ONCS until P3 data based on 10000 patients is available. It is clearly the only way you can be sure.
You can help: What sample size is needed? As an investor you better be prepared to make the decision on the sample size of 4 because if you wait for the full 41 it will be FAR to late. It MIGHT even be too late to wait for the sample size of 4. Never mind, I think you are right and I will just wait until after everything is announced to invest. It is much safer that way.
You are right. It is not like the CSO of ONCS was part of the team that developed MK-3475. Oh wait, he was? My mistake. I didn't catch your response on sample sizes? I guess the executives at AZ just do not know what they are doing. Maybe you and I should apply?
You're right, probably not. After all, ONCS would need to have someone working on licensing agreements and potentially marketing. They have no one to do that, right? That deal that INO got was pretty bad anyway (sarcasm), so remind me what sample size you would have recommended so they could have gotten a better deal (said with great laughter)?
What happens if AZ decides to lock up the market and offer a similar deal to ONCS? By the way, what was the sample size in the PI/II studies that AZ used to make their decision? I hope it was significantly larger than 41. No one should ever make a decision based on such a small sample size. I wonder if a competitor to AZ might get nervous and offer an even better deal to ONCS? Nah... that could never happen, could it?
I am not sure why the following is being deleted as all of the information is relevant to ONCS and establishing the good work they are doing:
1) continues to hire employees: https://www.linkedin.com/job/oncosec-medical-inc/jobs/
2) has a CSO with a recent article in a prestigious journal:
http://www.nature.com/nature/journal/v515/n7528/full/nature13954.html
http://ir.oncosec.com/press-releases/detail/1644/nature-publication-co-authored-by-robert-h-pierce-chief-scientific-officer-oncosec-medical
3) Are presenting an oral presentation in the near future at a well respected conference:
http://www.europeancancercongress.org/Scientific-Programme/Searchable-Programme#anchorScpr (Hint - search for pierce in the author field)
Sunday September 27th, 18:10:
Intratumoral delivery of Interleukin-12 DNA via in vivo electroporation leads to regression of injected and non-injected tumors in Merkel cell carcinoma: Final Results of a phase 2 study
Speaker: S. Bhatia (USA)
4) Have collaborations ongoing with reputable companies such as Perkin Elmer and Heat Biologics:
http://www.perkinelmer.com/corporate/stories/antibodies-to-fight-cancer.html
http://www.heatbio.com/news/press-releases/detail/414/heat-biologics-inc-and-oncosec-medical-inc-announce
5) Are actively receiving grants to help fund their research:
https://www.odu.edu/news/2014/11/reidy_center_grant#.VckYW-_bLPA
and on and on......
Some on this board have alleged that ONCS is a Pump and Dump. In my opinion companies that are pump and dumps do not do the following:
1) continues to hire employees: https://www.linkedin.com/job/oncosec-medical-inc/jobs/
2) has a CSO with a recent article in a prestigious journal:
http://www.nature.com/nature/journal/v515/n7528/full/nature13954.html
http://ir.oncosec.com/press-releases/detail/1644/nature-publication-co-authored-by-robert-h-pierce-chief-scientific-officer-oncosec-medical
3) Are presenting an oral presentation in the near future at a well respected conference:
http://www.europeancancercongress.org/Scientific-Programme/Searchable-Programme#anchorScpr (Hint - search for pierce in the author field)
Sunday September 27th, 18:10:
Intratumoral delivery of Interleukin-12 DNA via in vivo electroporation leads to regression of injected and non-injected tumors in Merkel cell carcinoma: Final Results of a phase 2 study
Speaker: S. Bhatia (USA)
4) Have collaborations ongoing with reputable companies such as Perkin Elmer and Heat Biologics:
http://www.perkinelmer.com/corporate/stories/antibodies-to-fight-cancer.html
http://www.heatbio.com/news/press-releases/detail/414/heat-biologics-inc-and-oncosec-medical-inc-announce
5) Are actively receiving grants to help fund their research:
https://www.odu.edu/news/2014/11/reidy_center_grant#.VckYW-_bLPA
and on and on......
Sal,
While I respect your opinion, it seems as if your personal dislike is clouding your judgement. How much cash does ONCS have on hand? How many outstanding shares? To imply that the company is only worth 1.5-2 implies that nothing they have done nor are working on is worth any $$s. Yes, they have had to significantly shift strategy, but that does not mean they are worth 0. Additionally, there are many reasons a large multinational may choose to wait to announce any associations. This goes for companies such as Merck AND others. Some are bad, but some are good. Take a step back from the cliff. Scorched earth actions ultimately end up destroying BOTH parties.
That must also mean investors would not flee if 1 patient had issues. Thank you for clarifying.
Good question. For whatever you intend to use the data. A sample size of 1 in September as you so eloquently mention can be statistically significant for the investment community to decide to heavily invest in ONCS or to flee. It depends on what that sample size of 1 shows. If it was shown that the combination is toxic and caused death after 2 days I think that would be statistically significant to cause investors to flee. If the sample size of 1 showed complete regression of all tumors in all locations on the body I think that would cause dramatic investment. Statistically relevant from a FDA or traditional definition... no, nonetheless statistically relevant from an investing viewpoint.
So you think a sample size of 41 is appropriate?
Depends. Some humans act like mice, so might as well figure out a way to treat them all :)
What is the critical number of patients that they need. Clearly you believe 41 is too small. If you were designing the trial, how many patients would you need to prove the theory and why can you not do it with 41?
If we are talking possibilities, than don't you need to include the possibility of a 100% response rate? After all, that is what the mouse models showed.
Since we are clarifying what he said it should be acknowledged that he did NOT state the accelerated approval would need more than 41 patients. He did say it would depend on the data.
The key case to watch over the next few months is GM604 and the very public campaign for accelerated approval. There is a paradigm shift occurring in the drug development industry. You will not see the full effect for several years so the precedents you want will not exist. If you want to be successful investing you better understand the shift that is coming. You might be surprised on a case by case basis the decisions that will occur. GM604 may fail given some debate on the effectiveness, nevertheless, the paradigm shift is coming. Ultimately, for ONCS what happens depends on the clinical results. While unlikely, what would you think would happen if the results showed 100% response in the 41 patients? Since that is unlikely, it becomes more tricky to predict what would happen at lower response rates. I do not think anyone is stating that accelerated approval will definitely occur. However, if you investigate the design of the trial, read the literature on what is currently occurring at the FDA, and realize the following:
1) It meets the criteria of a terminal disease
2) No alternative treatment / unmet medical need (as it is designed to test outcome on those with no/low response to current treatments)
3) Predictable outcome based on theoretical cause of action + post treatment data to confirm cause of action. Remember the Perkin Elmer collaboration?
It becomes clear that if results are positive enough (and this is the key) then an application for accelerated approval could and is likely to be filed. Good companies do not wait for precedent, they set the precedent and pave the path to the future.
If that is the case than I am sure you will be able to provide a few key examples in which a drug was approved based on precedent.
The American legal system is a precedent based system. The FDA system is not a precedent based system. End users use previous FDA decisions to help predict what they may do in the future. The FDA acts based on criteria and merit and not precedent. It may not seem that way all the time, but there is a subtle and substantial difference.
Concerning precedent for approval based on P2B results - I'll leave that for you to research since any data or example I might give you would be summarily dismissed for a myriad of reasons for which I do not care to argue about. It is better if you find the examples and draw your own conclusions instead of relying on what I might provide.
Over the last week I have been trying to figure out why Oncosec decided to hire a Vice President Of Market Development. The answer is not clear. If you look at the normal hiring trend, ONCS has been hiring for positions of need well AFTER the actual need. This is normal for a small company in which once responsibility/time commitment gets too large they hire to provide relief to whoever is doing that task at the moment. I understand the timeline for the combo trial and potential results, but that is in the future. Maybe ONCS is being proactive in this case, but given the historical trend it seems odd. Despite my best efforts I have found nothing to point to why they need a VP of Market Development now nor why they might suddenly become proactive if you assume this is in relation to the combo trial (i.e. they do not seem to be past a point of real need). Anyone have any data or figure anything out in this regard?
You have no data to back up that statement. The criteria is pretty clear and it does not include a set number of required individuals as you seem to imply. It might be your opinion that it will not qualify, but it is not your opinion nor mine that will matter. Just as I can not predict with any certainty that it will happen, you can not predict with any certainty that it will not happen.
On the contrary, I believe you misunderstand and need to research in more depth. You might start by reading a bit more than the summary on the FDA website of which you reference. The PDF on the same site located here http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf and the table on approximately page 8 might be a good summary. Further, you might search for the list of cancer related drugs that have received accelerated approval if you wish to improve your knowledge.
In no way do I mean to imply that it is a certainty that the combo trial and the 41 patient population will result in accelerated approval. However, if the trial achieves it's results there is a VERY real possibility of an accelerated approval. You might disagree, but probably not if you were one of those who were diagnosed and found that Keytruda and other methods simply had no impact on your survival rate. You might call the combo an unmet medical need and one which demonstrates an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, and which has a meaningful advantage over available therapies. Of course, that all hinges on the combo data showing what those who are really invested in this stock really hope it shows. Argue all you want, but it will not change what happens in the long term. Good data will = explosive stock price appreciation. Bad data = explosive stock price depreciation.
You should look up the term "accelerated approval" to get your examples. It is up to you to do your own DD as you have reminded us of so often. In general a P3 is still required to confirm results, but that is only AFTER approval and is done to confirm results/safety. Spectacular is all in the eyes of the beholder, or in this case whoever might offer a buyout. I will leave it up to you to define in your mind what spectacular means.
Depends. If the results are spectacular enough given the current known safety + data from the new 41 then a registration trial might be able to be skipped. I'll use a phrase you have used in the past, "It all depends on the data". Regardless, it is not materially important because a buyout at prices you are not willing to admit will occur if the P2B shows what it is supposed to show. Punit might not always make the best decisions, but he is smart enough to take the $$$ that will be offered. Have doubt if you want, but my chips are on the table for a good reason.
This is wishful thinking as the Perkin Elmer protocol is to look at data during biopsy. Tu Diep stated this back in December. Obviously something could have changed, but I doubt this is the reason.
I guess we will find out in 1-2 weeks.
I am sure they read these boards and have been told the essence of my message numerous times. Maybe they will finally learn two simple rules:
1) You can not tackle all problems at once. Therefore, you do not need to publicize everything that you are trying to tackle. If you do, you have set yourself up for failure as typically at least half the time you will fail to meet key milestones. Instead, pick the critical few that are most important to talk to the investment community about. The top 3, no more. Keep them well informed of BOTH success and failure. Trust is an important factor as eventually you will run out of individuals to mislead.
2) Recognize that real science and engineering progresses at a schedule that typically is outside of your control. The trick is to know enough that you can roughly estimate what that schedule will be, and then you add a safety factor. This ensures that you will under promise and over deliver instead of over promising and under delivering. At the end of the day, you can only do so much to accelerate schedules. Once you have committed, you best execute because for any given schedule and set of results the key stakeholders (in this case shareholders) will view your progress as positive if you do it faster than you said and negative if it is slower than you said. It matters what you do RELATIVE to what you said you would do. It is perception of the execution that is as critical as the actual execution, especially when you are relying on that perception for $$.
It is real simple: The science has not failed. There is still great hope and promise. Yet, the view of the company is currently negative. Why? Simply perception - ONCS has over promised and under delivered.
In the long run maybe it will not matter. However, I currently view it as a compounding interest problem. This means all current investors have lost potential long term gains. Let me be clear, it does not mean the long term gains will not be great, they will. It just means they will not be as great as they could have been. I am looking forward to the initial launch of the combo trial as that starts the real clock ticking.
I am disappointed because they did not take full advantage of the opportunity. They have made many decisions simply based on the science and fail to understand that they need to consider both the science AND the market. Yes, there have been some execution issues that help contribute. However, a great deal of it is that they want to approach the task simply based on the science. They believe that if they build it, price will follow. They use naïve methodology to try to bolster share price that is too predictable. Up to this point it has enabled significant manipulation of the share price. ONCS needs to understand that their ability to raise funds and hence survival as a company in the future IS tied to the overall market sentiment and share price. Currently the sentiment is negative, solely because they have done a bad job of controlling the narrative. They must enable POTENTIAL shareholders to understand the potential future value and demonstrate to current shareholders that progress is being made. Ringing the NASDAQ bell without something to excite current and future shareholders is like holding a raffle without a prize. When you tell everyone to look at you, it is best to have something important to say. I know timing does not always allow the ideal situation. However, the best make the timing happen.
Clearly the company is growing. They continue to hire and expand. This is a good sign as they have full belief in their potential success. However, currently the market does not understand the progress they have made nor why there are delays. By choosing not to explain they let the market pick the direction and narrative. It's too bad, because the stock could be double what it is worth now if they had done a better job communicating. That translates to higher prices down the road, less dilution, and easier ability to raise funds.
Hate to say it, but I told you so. ONCS is a very predictable. This might change in the near future.
I am guessing based on stock price action that no announcement is forthcoming and it is simply ringing the bell. On the other hand, I did find this job opening interesting:
https://www.linkedin.com/jobs2/view/70604365?trk=jserp_job_details_text
This is a good sign. It means the business has grown enough where Mai Le can not handle everything on her own.
If I remember correctly, INO has had multiple bell ringings. The first time they did a ringing the stock did increase. However, it really all depends on what comes along with the ringing. If they only ring, it will still help get their name out there as they just came from the OTC and are really not that well known yet. If they ring AND announce something real, then things could get exciting.
Ringing of the bell is an advertisement in and of itself to make more people aware of the company. It will be interesting to see if they combine this with an announcement of some sort. It could be official start of the trial or some type of results. It would be smart to advertise AND get people excited about the company. We'll just have to wait to see if/how well they planned this.
For those of us who have been here long enough to remember the Great Tweet Debate that was pretty funny. We'll see what next week brings.
Amazing, as this is one area I fully agree with you. While ONCS management has done a lot of good in other areas there is no getting around the fact that they made mistakes when it comes to this pivotal trial. Anyone arguing otherwise is just blinding themselves to reality. By working on too many things it distracted them from the key task at hand. They made assumptions that caused unnecessary delay in the pivotal trial because they focused too much of their time away from that which was most critical. As a long shareholder it is disappointing, but it is being addressed and the trial should start soon.
You can see the slow response and recognition of the problem in the position they opened to hire a Manager of Regulatory Affairs. This should have been done back in December. However, this is typical of companies at this stage. Sometimes you need to live with the bad as well as the good. Resources and $$ could have been applied to help ensure that UCSF was on track. While UCSF is going to conduct the study, it is more critical to ONCS than UCSF. This means both constant follow up and supplying resources to help with key tasks and review of critical materials.
I am sure IR is getting an earful on this topic. At this point we know there are no critical issues, but they do need to complete the process. Maybe now, they will do it with more of a sense of urgency.
Although the potential exists for a much higher price than $0.5-3B it is unlikely to happen as it assumes that the buyout does not occur until much later in time. The reality is that the buyout is likely to occur when initial data is available, not down the road after approvals. Once the potential is confirmed enough that the risk has been lowered, than given the current immunology market ONCS will be swooped up. I would be unhappy at 0.5B as I believe in the potential and believe that would leave a lot of $$ on the table. However, I would happily take $3B if it happened within the next 6-12 months. A bird in hand is more important than a what if that might never materialize.