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The bigger the problem of drug resistance bugs become, the more successful the launch of ervicycline will be in 2017-18. It's important to understand a very fine detail: ervicycline will become drug of first choice since it is effective against all the resistant bugs (except one) and it will likely have an oral formulation. All the drugs currently in P3 will become a drug of last choice because they are effective against limited number of bugs, and will require three IV injections per day.
This fine detail gives a market availability of many billions of dollars. Therefore, E could become a multi-billion dollar drug in its first year! That could push the stock price into the hundred X dollar range. I am buying more.
If you listen to Aug. 24 investor conference at TTPH investor relations you will discover that Intra-abdominal infection P3 (cIAI) is to starts in fourth quarter. It is expected that trial will take 12 months. This is the Pivital trial for drug approval (second successful trial). Additionally, a cUTI P3 will start soon for label extension, expecting to take year and half. Important take away is the prior failed cUTI has been created to food effect on oral formulation. Also, Ervacycline is becoming more valuable as more bad bugs stories are suggesting run away ptroblem, with no other P3 drug in pipeline by other drug companies with same effectiveness as Ervacycline. Cash position is good, with enough to carry through all existing trial activity. Truly a remarkable buying opportunity. Be ready for long term hold before any substantial value increase (12 months). Although ...
I'm not sure it's safe to assume anything with regard to these companies. I notice you do not mention the critical P3 for complicated interabdominal infection. That is the Pivital P3 for drug approval. ThecUTI is planned as a label extension trial. So much for projected timelines. The stock price is dead at the moment, largely due to a noticeable lack of activity. What biotech is not interested in communicating with the investment community? I suppose management could be in talks to sale the company. But I see that as a very long shot without a drug approving P3. Love the potential for the company, given its science. However, a lot of people have lost a lot of money because of this management team!
Haven't seen a P3 start yet without an announcement that it was getting underway with its first dosing. Of course that makes sense from an investor relations perspective (perhaps regulatory also). I have not looked to identify the details of the P3.
HI Xena, The new P3 for interabdominal infection is expected to take around 12 months. I have not seen any announcement that it has started. That might be reason for the loss of market value, and certainly supports a question mark about the ability of current leadership to manage this process. A second P3 for cUTI is also to be conducted but it also has not launched. Just wonder if anyone is steering this ship. Assuming a start today I would expect value returning to the company in about 12 months! That would put us at about this time next year.
Price touching high $3.90 range. Truly an exceptional buying opportunity. Any lower and I will be buying with both hands. Why? The science is compelling; the license ownership of synthetic process is moat creating; the variant compounds are 3,000 strong potential blockbusters (no other pharma can boast this); the passage of next trial is almost guaranteed; the time to approval is about year; the cUTI is close behind and will carry Hugh commercial success if oral arm added; news any day of trial kick-off which will bump price. Stock was valued in excess of $50 based on expected passage. The guys have identified the reason for failure and have corrected for that. One year away; value should be $9 - $15. It will get there. Once it starts it will be quick!
Sorry, one misstatement; it failed the cUTI P3 due to miscalc of food effect on oral formulation. Anyway, I keep buying on dips. Hugh value will be unlocked within year. Most two.
The company doesn't communicate because there is nothing new to say. All information is contained in the quarterly conferences and special medical and/or broker/dealer conferences. We know that the timeline for completion of Pivital P3 compicated interabdominal infection is one year and the label expanding cUTI P3 is six months longer. We should know that they will pass the Pivital P3 because it's a repeat of an earlier trial it has passed (this is science after all). So we are a good year away from drug approval. Maybe they will define the ability to bolt on a oral pill arm on the cUTI as that would yield Hugh commercial benefits (dependent on the current P1 evaluation of saturation of oral formulation into blood). Maybe they will get a big buy order from DOD on the antibiotic to address terrorist initiated bio-threat. Or maybe pushing new compound into clinic (though doubt that pending conclusion of P3 due to cash concerns). All things considered, buy as much stock as you can afford at these bargain basement prices, but expect to hold for 3 to 6 months before trending begins increasing stock price. Stock could start a sustained rise due to the intrinsic value of the license for full synthetic production of tetracycline and the 3000 derivative compounds already created by this company, but market appears oblivious thus far (due largely to the miss of P3 for interabdominal - which frankly was faulted by miscalc on oral food effect). So my take is this a short to moderate term hold before value accures. But, certainly don't buy and expect profits tomorrow.
Whether it's FUD seems highly speculative! I have seen angry allegations that dialectic conversations were FUD! I think the categorical assumption that negative means FUD is lacking critical thinking and frankly, I have no use for it. Thanks for your perspective.
Interesting. Many investors simply scan headlines, thus getting the signal completely wrong. I would wonder which is correct, but with your input, I now know.
Looking at the mistakes closely leads to conclusion that they are completely random! How the market reacts is not, however,
Of course, if the FDA makes an exception for AKAO's antibiotic candidate, well then those guys will have some explaining to do to TTPH shareholders!!
The market will be bent when it discovers that AKAO can't get NDA accepted for only one P3 (I believe Guy stated that "never, ever has an antibiotic been approved on only one P3")!! So TTPH is going to ride to a really fine finish, well ahead of the compition. A little surprising TTPH is sluming in this price range neighborhood. Look at the investors conversation at investor village to see the carnage this price collapse has brought to individuals. But, the future is bright. Just look at the science, lab results and you can see this is a ship on NASA launch site!!! The stock is just getting punished for disappointing the market. Eventually greed will drive this stock much higher. Expecting buyout announcement any day!!
Oh, oh, oh, one other thing! If the boys in the lab can just get the pill formulation right to deliver therapeutic doses into the bloodstream, tand drop that as an arm into the new P3, then you would have a HUGH value play! Essentially it would take the market! Well, certainly for cUTI.
However, I should hasten to add that the exclusive license for synthetic manufacturing of Tetracycline should be valued quite a bit higher. Not to mention the 3000 derivatives they have in the lab already. I think given the acquisition storm brewing in pharma we could see a significant bid for this stock! That is the outlier here! That likelyhood increases as Congress sweetens the tax benefits for research into antibiotics! Good luck
Yep, the cUTI P3 miss was a major FU, but the guys are trying hard to get it right this time. Getting some really wise guidance from FDA, or at least very conservative. The stock is caught in the "we don't care" vortex! But that will change. If I only knew when I'd be a lot richer! But at minimum should see climb in price beginning prior to conclusion of New P3n. Thankfully AKAO is not doing Pivital P3 in IAI, but are only in cUTI, so that TTPH doesn't have to worry about head on compition on trial completion. AKAO is due to complete P3 in cUTI first Q next year. Be thankful they FU their IAI P3. Anyway, you are probably 8 months early for any value climb. That comes with so much institutional ownership. Nobody needs to buy! But, admittedly, the three dollar range does seem like the wrong neighborhood for this gemstone!
Nervous Investors is reason for stock decline! IDCM review should have been announced, so fact is this is the 50% interim review (IDMC did not have to say when that would occur). That gives a lot of information to investors. At this point the IDMC must review data and determine whether it would be futile to continue trial! If the Committee gives the go forward signal to the company, then this stock should gain substantial value, and stock price. Alternatively, if the next thing you hear is the company announcing a futility finding, well...
Or to be more accurate, the apparent attitude of corporate officers!
Its not like a rumor about the DMC conclusion has to be from some sinister source. It could be as simple as someone observing the attitude of Committee members as they broke from meeting. Upbeat an jovial attitudes does not square with a decision to stop a trial. Seems clear the rumor is the DMC decision is a go. So to continue the trial.
Just to be clear, it's likely the 50% interim review! Though the IDMC is not bound to identify that fact! It's just going to be continue the trial, or stop for futility (or stop as data supports passage)! Very important moment for stock! Clearly rumor has it ....
In the universe of antibiotic players this is the king! TTPH has 3000 synthetic derivatives of tetracycline already created and in the lab. That is possible only because it has the ONLY synthetic method of manufacturing. As soon as the market has the time to understand the reason for the miss on the P3 for cUTI was food interference with oral delivery, and the new probabilities that a repeat performance of the P3 for inter-abdominal infection is better than 90% probability (given high pass rate of prior trial pass rate) (the new criteria for NDA acceptance by FDA) then it's "to the moon Alice"! Of course, some people need 100%. But those guys aren't in equities anyway.
So, expecting $5 is really not getting the picture of the value of this stock! Looking down the field a ways I see the value being caught by price! Just a matter of patience! Warren B trueism
I am guessing the rumor is that the Data Monitoring Committee is giving a go to the trial after the third and final review prior to completion. That signal says that the trial is on track to show efficaciousness! This review is the critical point for determining a winner (aside from a. Final review, of course). Expect a surge up from here! Expecting stock to top 52 week high very soon!
http://www.streetinsider.com/dr/news.php?id=11661943
ASH Microobe conference presentation on almost everything. Will be in Boston.
So if you haven't done so already, I'd scoop up these cheap $50 bills while there almost free.
I once worked for a public corporation; big one. It's interesting to me now how much information about other companies was accumulated. I don't think I need to send this review of P3 trials to any pharma company that might have interest because I'm pretty certain they already have it.
What I find interesting after reviewing the presentation about egnite1 and 2 is the closeness to which this study came to passing: only 4.6% short on an obscure criteria. When you look at the lab studies of the efficaciousness of eravacycline with all these bad bugs you recognize the "wow" factor of how impressive this molecule really is, as only pfizer's Tigercycline comes even close! I really understand the frustration the Leadership team feels about getting rejected when they have something as special as eravacycline. Pfizer gets to keep the exclusive leadership role for another two years. I expect given the value of TTPH's synthetic process, Pfizer will come knocking soon.
http://files.shareholder.com/downloads/AMDA-1P4BOP/1865481235x0x888083/B2ED3741-6DB5-4608-8AAF-F64A6AF6DD0F/Tetraphase_April_2016_Needham_Presentation_FINAL.pdf.
Presentation showing efficacy against gram negative pathogens! And full review! Worth the time to review!
SUPER Bugs are on the rise and the recent news story you cite is dead on point! The value of TTPH is rising for any large pharmaceutical player, as it would be a bolt on money machine! The unusual aspect to the area of antibiotics was stated by the CEO a month ago when he identified the area as being one in which the FDA required two passed Phase 3 Trials before that Agency would grant approval to a NDA. Indeed he stated "never has an antibiotic been approved on one P3 trial". See TTPH web Cite and transcripts. This revelation makes the price action of the stock upon news of the FDA decision confused, as it suggest that stockholders are not listening.
Certainly, more than a few shareholders will miss the significant escalation in stock price once the drama has passed! Given that NDA approval will occur upon a repeat performance of the spectacular performing cITI Trial, and, understanding that this important point will draw interest from large pharmaceutical players as they know it's science (repeatability lies as its core belief). Perhaps more importantly, the leadership team has also stated that food issues are believed to have interfered with the cUTI Phase 3. The current P1 is examining this issue and dosage for the oral pill formulation of eravacycline. The hope is to have data supporting an add on arm to the cUTI P3 trial (label extending trial). All together these developments support a strong position of inevitable outcome predictability, and accordingly, risk rationalization. That is the principle concern of an acquiring pharma. That suggest the possibility of a suitor arriving any day as the spoils go to the smart and brave.
Perfect target for M&A!! Let's consider tHe reasons why: 1). The science is clear from P3 cITI passage that eravaclycline treatment works; 2). Stock price is at 52 week lows; 3) patented compounds are robust and constitute significant pipeline and there are 3000 additional created compounds ready to study; 4). Top shelf science team with proven collaberation skills; 5). Majority of shares held by rational acting funds; 6). Growing demand for broad spectrum antibiotics. 7). Broad and deep moat around ownership of synthetic creation and manipulate of tetracycline compounds; 8) cash from continuing operations WILL be in billions!!!
If we are lucky the cUTI P3 will include arm evaluating IV to pill transition, as this is one of the major efficacy benefits of eravacycline. Chief science officer indicated this might be possibility at last conference call. I would expect to see more on this point as P1 of oral pill formulation unfolds in next few months! The data they need to understand is the volume of medicine in pill needed to produce efficacious results (volume of ingestion to blood volume). Also there is a significant food effect, understanding this more fully will be important!
Eravacycline is one of the most efficient antibiotics currently ready for P3 testing! See the published data from TTPH comparing activity against all the "bad bugs". So why is TTPH at a near 52 week low? Simple: the P3 team were too aggressive with testing protocol with the objective of winning the preferred drug status on all UTI infections. 3 day IV and remainder on pill formulation as a treatment protocol would have won top pick since every hospital wants to move patients out of inpatient care as soon as possible; IV treatment is big drag on achieving that objective for UTI.
So where are we at with new trial? TTPH will not risk failure again, so the P3 trials are all designed for overkill!! These test will kill the bad bug within 10% of efficiency of comparator. So rather than once a day IV they will do twice a day IV, thereby getting more drug into the blood! Accordingly, given the proven power of eravacycline's effect on bad bugs it's clear the design of P3 is to use sledge hammer for a finishing hammer's job, solely to ensure passage of P3. Rightfully so however, time for nuisanced differentiation of eravacycline's performance ability over comparators can happen later. FDA just wants this drug to pass the G**** Test!
New P3 for cITI (inter-abdominal infection) and second P3 for cUTI (urinary infection) are both planned on highly conservative treatment plans. The replay of cITI is an easy pass and FDA has agreed that it will be bases for drug approval. Label expansion will be based on cUTI trial, which is planned as much more conservative P3 so as to ensure passage (two IV application daily whereas the original failed had three days of once daily IV transitioned to Oral pill)! The stock has taken its hit but should gain value from here as the plan forward is tO gain approval for drug within 16 - 18 months time based on test that has high probability of passing, since it's a repeat of prior passed P3! Time to quadruple down. Adequate cash for trial completion.
Let me get this right? I have to wait one year for this company to do a P3 over again that it passed on a double blind previously, and my reward will be around $25 to $50 per share? You are kidding me? Right! What better odds could you possibly get than that deal!! And the stock is falling in price! What --- would sale his stock on that deal for these prices! Best pick these shares up by the bucket full!! Quick before everyone figures it out! I mean do you see the institutions selling?
Austin,
I would also note that were the company being considered as a target, and in conversations with a buyer, often its a precondition to purchase that the target do housecleaning with staffing numbers prior to the announcement. If anything the house cleaning provides greater support for the argument that ARGS is indeed a target for purchase. I have no information on this issue. Just saying if that were in the works!
Frankly, this P3 is looking good. When the 3rd interim review is completed by the Data Review Committee you should see a substantial rush up in the stock price. Assuming you wanted to get out early. And on passage of the P3 another multiple of 100% rise. I am long this one.
Austin, this is a lemming's response. Also a brain dead one. Whatever was driving the rise in value could not be damaged by changes which create greater efficiency in the organization. The concern is about some "problem" that could impact the trial. Based on public announcement that is not a concern anyone should have.. Based on private investors putting additional $60.0m into company I would bet that the efficiency drive is part of that financings requirement. Long story, short: great opportunity to buy back. Look for intra- day lows. One possible concern is resignation of COO and impact that might have on organization. REALLY?
The shorts have not covered because they still believe its going to fail. In fact I think you might have a hard time finding shares to borrow in order to short (suggesting a lot of shorts are out). Its a dynamic stock so looks like you could find an opportunity to buy in at some point. Regarding selling at a profit; I have never been unhappy about taking a profit. You cannot sell at the top, except by luck. How high this stock goes is dependent on whether it passes this P3. The upside is quite substantial if it does pass. But anything can happen since things come out of left field. I am going to hold a fraction of my stock till the end. Most of it I sold off and took the 200% profit.
Also it is interesting that this is not truly a blinded study. Although the insiders promised monitoring committee not to look. That does not explain why insiders hold 60% of shares and are acquiring more as P3 approaches third interim. While suspicious, I would not invest based upon those facts. Rather consider the head and shoulders clearance likely hood this P3 has of passage. Once monitoring committee pass on third interim this stock is truly going to become unattainable at any reasonable price, given the float is only 9.5m. Heck yesterday's volume was almost equivalent to 10% float. Poor shorts were at 1.0m. Time to cover is way past due. But question is, have they, covered?
Been so long since I reviewed this stock. I believe the Median overall survival of the P2 participants was 64 months longer than the standard of care. That is a bit different that 64% better. It is an enormous step up. The P3 is targeting on a four month MOS better than SOC. Really a powerful therapy. The best projected value from SA, that I have seen, is $56 share. That will develop once it passes P3.
Austin,
I wouldn't rub it in too much. Not worth the effort. But the real question is whether to hold for the trial to finish. The P2 was a 64% better result than standard of care. Lot of upside still coming.
Interesting idea. So that is why LP want to have an independent audit done all along! We are sure to get to the truth by the review of facts from this top Ex-FBI Investgator/Director. A little odd choice by Woodford. I guess he might be uncertain as to what the truth is here. I wonder if the shorts are afraid? Any sign of covering?
RK,
Interesting way to look at the evolution of medical treatment for GBM. I had not considered the improvements in surgical procedures as a possible reason for some part of the claimed success in the P1/11 trials. That association is quite interesting and self proving. Well, almost self proving. Are there any studies showing the benefit of MRI enhancements, and total resection, in GBM without other treatments (I am thinking not since Stupp is the proven method, and multiple arm study for MRI usage was probably not required). Otherwise, your reference to research on this issue is quite sufficient. Thanks
I know someone who I shared a few beers with that has an inoperable GBM grade IV. Not totally sure, but think that radiation may not be an option due to location. Total reliance on Chemo. That family is in total shock. I don't think any mention of the NWBO Vax option even makes sense. The tumor load is just way to significant to even theoretically benefit from L. Your review of those associated numbers was very helpful. I have weighed that issue because if I thought there was any hope from L in that circumstance I would have raised the possibility. Even so, he has a top team and am sure they have considered every proven option. Sometimes we just have to face the inevitable. I need to remember that.