I agree it is more about insisting on some clinical like parameters for the drugs use and then gathering as much information as possible. Would be great to make it simulate a trial as much as possible but you can't exactly do that. The hope I believe is to gather info in a way that will accelerate the clinical process. In any event I believe that 1) the drug will work and 2) the short term PPS of TKMR will go parabolic as soon as news of the first dose reaching Africa hits
Yes. The key as you say is the between the lines at the conference call. TKMR says (paraphrased) that "there currently is no regulatory pathway for use of ebola drugs in Africa." Yet Z-Mapp had already been shipped, WITHOUT ANY ESTABLISHED REGULATORY PATHWAY FOR IT'S USE. So, there indeed is no regulatory pathway, but our government is not requiring one, nor are the governments/entities asking for the drug. Again, the only logical conclusion is that it is TKMR itself that wants to regulate how TKM-E is distributed and used.
They halt it before releasing the news so as not to allow trading before everyone has the same information. When the FDA announced the change of the full hold to a partial hold a couple weeks ago, I believe trading was halted after hours at like 4:01 PM, with AH trading resuming shortly thereafter. BTW if you check my prior posts you will see that I did predict that there was a medium possibility that the FDA would release the hold for sick people, and it happened a day or two later.
Not necessarily. Could be at any time though. This is my thinking. The stock tanked after the Conf Call after TKMR management said their is no "regulatory pathway" for use of the drug. It tanked bc those words were misinterpreted by listeners to mean there is some type of REQUIRED regulatory pathway which is a barrier to TKM-E use in Africa. NOT SO. We know it is not so bc Z-Mapp was shipped and obviously since TKM-E also has green light from FDA, there was no regulatory path established at home for distribution and use of Z-Mapp, and thus none is REQUIRED for TKM-E either. The astute listener should realize that it is TKMR that WANTS ITSELF TO ESTABLISH A REGULATORY PATH for use and distribution of TKM-E before sending the drug, so they can track it and perhaps mirror a clinical trial. TKMR is dictating and/or negotiating the terms for use of it's drug. The drug is superior and farther along clinically to Z-MAPP and TKMR is not ready to send the limited drug inventory to the first few people/entities that ask, as was Z-MAPP. Rather, TKMR's astute management will help people but the best way to do that is not just to get the drug to Africa at the first possible moment, rather the goal of helping the masses is best served by not just getting TX to those that need it, but doing so in such a way as the clinical program will be accelerated as much as possible. In sum, it could happen today, tomorrow, or in 3 weeks but I think it is an excellent bet that it will happen quite soon.
1) HALT of TKMR trading will be announced
2) TKMR and/or WHO announce plan for distribution/use of TKME in Africa (possibly limited to TX for sick healthcare workers).
3) Trading resumes at $25-$30/Share, for starters.
The above is so predictable and probable. Can't believe that more do not see this coming.
Sentiment: Strong Buy
Shorts don't get it. Tekmira is in the drivers seat. Tekmira is without question the most studied cure with the most successful data to date (easily superior to Z-MAPP). It is TKMR and nobody and nothing else that wants to work out a regulatory pathway, ACCEPTABLE TO ITSELF, before distributing the drug to humans sick with Ebola. There is absolutely zero barrier to use other than the company itself. THERE IS NO OTHER LOGICAL POSSIBILITY. Understand that there is no "regulatory pathway" for the use of ANY EBOLA DRUG, yet Z-Mapp sent their INFERIOR drug to the few who asked. THE U.S. government, via the FDA, has sanctioned the use of TKM-E in other countries. Tekmira will ship TKM-E, as soon as the procedure for distribution and use is agreeable to TKMR.. I am going to get rich on the misinterpretation of the conference call., and all of those that wrongly interpreted TKMR management's conservative speak to mean that TKMR has regulatory hurdles beyond what I have just stated.
So misinformed. Z-Mapp also had a 48 hour testing window, but was craved for use in Africa. The cytokine complication in a single TKMR patient is easily addressable with steroids. However, as per TKMRS last conf call, this VERY conservative mgmt. team expressed extreme confidence that they could address the issue with the FDA without premedication with steroids (which they do not want to use)and were extremely confident they will do that and resume human testing within couple months. Of course if you are dying of Ebola, as opposed to a healthy volunteer, you are not too concerned about a rare cytokine complication anyway. Whether short or a basher paid to misinform, you need to face the facts that the only thing holding up TKM-E use in Africa is TKMR itself. They want to do it right and have plenty of time to work through the process and dictate the terms for use of their inventory of TKM-E. IMO it is an inevitable and imminent event that as I have said will catapult the PPS as soon as the first dose reaches Africa. This could be the dumbest short ever.
The holdup for use of TKM-E in Africa is for the establishment of an "regulatory pathway" for use of the drug. What regulatory pathway could possibly be required for TKM-E, which was not required for Z-MAPP? The answer, in light of the fact that the FDA already lifted the hold for compassionate/emergency use, is NONE. Thus, it is TKME itself that wants to establish an acceptable plan for distribution and use of their limited supply of TKM-E, before allowing it's use. IMHO there is a very high probability that any day or week this stock will be HALTED and the news will be about the first TKM-E doses going to Africa, and the plan re how and to who the drug will be distributed. That is when this thing will explode. I believe it will work, but it doesn't have to. The simple announcement of the use of the drug will send this to $30 in a heartbeat. Short at grave risk.
Sentiment: Strong Buy
Totally false. The TKMR drug is completely ready. The regulatory pathway for its distribution and use is not. Give it a few days or weeks for the distribution plan to be worked out thimblebrain. Funny to see a moron calling others morons.
and of course I bought my 250 september options contracts yesterday, as posted, before the article about smart money doing exactly that. The action today may be meaningless, or not. But TKMR will get TKM-E to Africa as soon as a distribution and use plan is agreed upon. IT WILL HAPPEN AND SOON. You have to trust your own ear when listening to people talk (ie; the CC), and understand the mentality and motive, or lack thereof. of those that are talking. Enough said.
....AS soon as TKMR is there is a plan, pursuant to TKMRs ongoing dialogue with the WHO and African countries as to how to distribute and use TKM-E, this drug will be in Africa. It is a matter of 1-8 weeks. Probably more like 1-4 weeks.
Sorry but I do have my hand on the pulse of this. I called the release of the full hold to partial hold for the sick before it happened. Check my posts. This morning I called that if we are lucky the epidemic could be controlled within 6 months. Check my post. News from WHO stating exactly that comes this afternoon. I HAVE SAID AND REPEAT that TKM-E gets to Africa within 1-8 weeks LONG BEFORE this outbreak is under control. AND as soon as the FIRST DOSE of TKM-E gets to Africa, the PPS goes berserk. The simpleton moron public has seriously misinterpreted the CC of yesterday whereby TKMR said they will wait for a regulatory path before distributing the drug. DUMMIE SHORTS...read between the lines. AS
yet 32 NURSES in Sierra Leone alone have died since late May? The governments are parsing words here. If it is technically not airborne it almost certainly is not true in the traditional sense of those words. Unless we are talking about an unusually promiscuous group of nurses who exchanged bodily fluids with the patients (bad joke), there is no way this is not in fact transmitted through the air at least within a few feet of the infected. If it is not airborne this is the most infectious "non-airborne" disease in the history of mankind. If lucky this will be under control in 6 months or so. IMHO TKMR gets 100 doses or so of the drug to Africa (preferably to sick health care workers in various countries) within 1 to 8 weeks. Again, I believe the words "regulatory pathway" were simply meant to say TKMR is waiting for a PLAN to be put in place through their talks with the WHO and the various Countries which TKMR confirmed are taking place. The misinterpretation by the simpleton masses of the words "regulatory pathway", in the context that they were used, is going to cost a lot of people a lot of money. Once a single dose of TKM-E gets to Africa, the reaction will be more parabolic than what we saw with the PPS when the hold was reduced to a "partial" hold. Just watch.
You have it wrong. They have a small inventory that can be used. The market opportunity is to skip through literally all phases of testing and see if it works now. The money to be made is later in US stockpiling of the drug, for starters. Mass production is not what they need right now. The stock will fly as soon as ANY TKM-E gets to Africa. My guess is it gets there in 4 weeks or less. Never saw so much idiotic misinterpretation of a conference call in my life. We will see who is right in 1to 8 weeks. What happens today or tomorrow is irrelevant to me.
Kip-I think that you actually overstate the roadblocks for use in Africa. They just need to establish a plan as to how to distribute and use (ie;a regulatory pathway) a limited supply of the drug. They can't just haphazardly send it to random people/entities/countries. Who will get the drug in individual countries to distribute, and how/what will determine what individuals within that country get that drug? They need to work that out bc unlike MAPP, TKMR has a small inventory of the drug. It's funny Z-MAPP and/or others got called racists for how they distributed just a few doses. People are so dumb they don't realize there has to be a plan (ie; regulatory path) before TKMR distributes 100, 200 or 300 doses? Everyone needs to wake up and have a few weeks of patience here.
Those are the facts. You can misinterpret the context for the words "regulatory pathway" all you want. The fact is there has to be a plan for distribution and use of the limited inventory of the drug. TKMR said they are working on that plan by speaking directly with the WHO and African countries. This is what longs want. Stock would be spiking absent inartful way this was stated at the CC.
Exactly. The use of words "regulatory pathway" freaked people out. I also think it is a matter of a couple of weeks before TKM-E is used in Africa. They will certainly monitor the results but I would not consider it a phase 3 or other trial. The truth is this is not like MAPP where there are just a few doses. There is an "inventory" that while relatively small, needs something more than a haphazard plan relating to who will get to use the limited supply. Hence the words "regulatory pathway". I have a core position and sold my play position which I bought BEFORE the hold was changed to a partial hold (ie;way ahead). I basically predicted the hold would be lifted for the sick in a prior post. You can verify that. I bought some options yesterday too for September and I think that 5 weeks should suffice to determine a PLAN (better words than regulatory pathway which was a poor choice of words-the FDA already gave the green light). I am happy for the longs like me that made money, and don't begrudge the shorts either, but continue to think this is a poor short. The shorts got lucky based on a professional non pumping attitude from the company combined with a poor choice of words used at the conference call yesterday. The longs that have no patience to read between the lines and see what is going to happen probably within just a few short weeks deserve to lose there money to the shorts anyway,