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Good stuff. Thanks.
Pfizer's Vaccination Business - Antibiotic Resistant Staph (MRSA) Opportunity
Could explain some of the lack of enthusiasm. Vaccines to bacteria. What will they think of next....
http://seekingalpha.com/article/1699172-pfizers-vaccination-business-antibiotic-resistant-staph-mrsa-opportunity
The hope (justified I think) is that with a much shorter exposure of one day the SAE goes away completely. It seems those who got it on high dose had the reaction on Day 2 and those in the medium and low had it at day 4 at the earliest. So the 1 day .6/kg has a very serious shot at no SAE's since it is a lower medium dose. There is also a chance that 1 day of the .8/kg is also below the threshold to cause SAEs - less sure because of the long half life of the drug may take you to day 2. But possible and if no SAE's best chance of efficacy.
Let me try to answer this question more simply. From what others have posted big pharma just hasn't shown a lot of interest in the antibiotic space. Not enough repeat lifetime customers like with cholesterol and similar drugs and sexier things like cancer cures. It seems big pharma simply willingly abandoned the space, not because it doesn't have value, but because it doesn't have enough value to them to be worth pursuing - remember total antibiotic space value was something like 1.5B in U.S. so getting a piece of that pie just isn't a big deal to them. Hence no interest in a Ph2a
Could they be proven wrong in their decision making - definitely. But it does seem that it is smaller pharmas that are taking the lead in the antibiotics space and I'm sure Cubicin was distracted by their other recent acquisitions. Trius is gone cause it got eaten by the above. Realistic to ask how many interested buyers could there have even been left to compete with our bid?
Just my two cents. But I think big pharma could have moved to acquire assets in bankruptcy without too much difficulty. Its just its not exciting enough for a big company like that to bother with such a small fry (to them at least - to us its quite large potentially) indication.
If there is one thing that even a skeptic like me has to acknowledge is that our management team is world class. World class. There just is no other way about it. They know how to pinch dollars and find deals that most wouldn't even think to look for - Aspire financing and this deal being two very good examples. Also just from a product development decision standpoint these guys appear to have made all the right moves.
You can be sure this management team will get the products to the finish line.
Even if they did I don't think they would dig too deep at this point. Makes more sense to offer after K is proven which is at latest June of 2014. Since they would be diluting themselves as well they have strong incentive to minimize the amount as they did with Aspire.
Cool stuff. I like the sound of $1B and based on what they showed that sounds plausible. I'm sure the lack of development of the surfaces came from, like all their other failures, having their legs cut off too far from the goal. When you are suddenly on life support you have to focus on what's furthest along in your pipeline. Imagine a biotech partnering with home depot though, haha. I say license that out once you prove it works.
The repost of the shareholder presentation has the answer to the dosing. We get .8/kg as the highest dose which is pretty damn high and it is a 1 day treatment so it should be exciting if that works.
a) 3 days (0.6 mg/kg day 1 + 0.3 mg/kg days 2-3) followed by 4 days of once daily placebo (normal saline); or
b) 1 day (0.6 mg/kg) followed by 6 days of once daily placebo; or
c) 1 day (0.8 mg/kg) followed by 6 days of once daily placebo;
Money... no idea. If I had to guess I would think Ph2 should have equivalent costs so maybe looking at $8-14M for our new trials (taking the high-low estimates of the B 2B trial).
We were always going to have to spend the money on P eventually though so the extra cost is really just B.
Unlikely that we would have any Company sponsored clinical trial for K begin in 2014 (since Ph1 likely won't be completely done until June)so my guess is we should be fine with another Aspire deal (ie $10M in additional funding) to take us into 2015
I think the reformulation was in reference to the 4th drug (begins with a D I believe and was a reversing agent of some kind) that we are not going to be pushing until reformulated or confirmed that diluting it will lead to safety.
So we have B which is great and shouldn't have any issues and time to confirm that D works if administered differently. Good stuff.
That is some very helpful color. So what do you think the yearly sales potential for B is given its ability to displace the #3 on the market (which looks like a $200M a year product)?
The other drug had an issue I think with hypotension (unsafe drop in blood pressure). This one had a few people discontinued because blood pressure got above 180 per the poster. The one who had hypertension (high blood pressure) in the low dose group had a history of hypertension.
Looks good. Is it just me or every time I see a data set for this trial the numbers change?
Outperforms Dapto on days 2-3. Slightly underperforms Dapto at Day 28. Interesting - wonder if that was just an issue with follow-up (seems likely).
Does anyone recall what the dosing on the Ph2B study is going to be. Seems that ideally we want a shorter dose, but at the HIGH level of dosing of 1 mg/kg for ideal results.
Here's hoping that any history of hypertension is an exclusion criteria. That should take care of the SAE's.
I know you are right. I just hope I don't have to wait that long :) Hopefully we get strong efficacy at Cohort 8 and we are off to the races :)
My dream is to become a guy who never sells a share and cheats the tax man by taking out loans to live on against the equity. Oh to be rich, haha.
I'm here because I think we will get there. My odds of success for K have always been closer to 100 percent but I am just an overconfident fool. How funny is that!
Fair enough. You are a smarter man than me with your post-ASCO decisions, haha. I have been burned putting money in "shorter" term plays in the past so I decided to sit stoic this time. Like i said hopefully I will avoid a massive cap gains hit when I finally trade on the big wave that hopefully is inevitably heading our way. Glad you have utmost respect for management. It never hurts. I guess I'm just more jaded haha. Probably from living in NYC or something.
I have to agree. Just some maybe over reach on how positive insiders expectations are at this point. Always Leo "knows", Leo "winks", if only Leo wasn't "muzzled". My response to all of the above is simply LOL. We are where we are and the trial will progress and if we are lucky we will get some actual news within the next 1-4 months. I am not expecting conclusive anti cancer activity until at least cohort 7 at this rate and would not be surprised if there was nothing very solid until Cohort 8.
Happy to wait and even happier to be surprised early but Christmas hasn't come yet :)
Best of luck to us all BioHedge. Enjoy your weekend.
Sounds like immunotherapy along the lines of CLDX. Not a direct competitor more than any other drug that beats any type of cancer. Wouldn't worry about it.
Some would prefer to ignore the qualifiers stated by Leo by calling them standard legal type disclosures and that he is being forced to downplay results. My point is that he hasn't downplayed anything. The results with the massive qualifiers is what we have. Those who would look to ignore the qualifiers and view it as a wink and a nod from Leo.... well lets just say historically those folks have been consistently disappointed when reality smacks them in the face.
We have unconfirmed P21 activation and with the qualifiers that is really all I see at this point that is substantive. Hence the share price.
Not sure where to begin on this one. Slight increases in P21 are not really proof of anything except that the drug is not a placebo. People are saying we have signs that K is impacting the growth of the cancer at these early levels. My point is that is a huge leap not backed up on any solid facts and extremely premature.
How many patients are we following over how many scans. Add it up and come up with what percentage 6 is out of all of those scans. Could start to look like a few errors. No way to tell for sure. Exactly why you can't draw any conclusions. Have to wait for additional confirmation. Remember our mice did not show delay at these dosages so lack of results is more likely than surprise efficacy. Lots of reasons not to jump to conclusions. But this board needs HYPE right!?!? So HYPE away. Surely the market just is way too overly conservative and you just need to show everyone what is what.
Or maybe it really is nothing significant has happened yet and we wait for higher dosages.
Glad you are excited. Lots and lots of assumptions in your rebuttal but who am I to rain on your parade. Ok ok i will try. I still say not easy to measure tumor growth if it is growing slowly no matter how good your tech is and note Stage IV tumors can still grow SLOWLY. I also still say stabilization followed by disease progression raises significant doubt about whether apparent stabilization was due to the medication. You think the tumor responded and then stopped responding at these dosages? Maybe, but I still believe it is reasonable to conclude and more likely that stabilization itself was an error of the physician/technician as a result of difficulty of measuring precise changes of the size of the tumor. Specifically - doctor looked at scans and thought disease stabalized because he cannot detect the slight growth and then another month goes by and now the change is enough to detect. Measuring changes in tumor size has always been an issue in cancer trials and one of the reasons nobody is comfortable with open label cancer studies vs blinded because of physician bias and error to see stabilization.
The market seems to agree that things are not quite as good as you say they are - at least not yet.
Useful info. Thanks!
You are off base Pete. I established my position for the most part in March and have no intention of changing until after Ph1 for K completes, if then. If you saw my holdings it would probably make your mind explode about how I could ever be negative. To give you an idea I am in the 100k share club. The funny thing is many jumped to the conclusion that my explanation was negative or intended to be negative. Maybe it was to others who believe management is infallible and could never tell a lie but I am not and will never be so trusting. From my perspective I was trying to put together an explanation that made sense and once it made sense well at least to me it didn't seem so bad. On the flip side if a decision doesn't make sense you are "covered by a cloud" of doubt bc you don't have a clue what is going on. Some would say just trust Leo. I can't. I need an explanation - a reason I can wrap my head around or else something may be very wrong. The official Company line wasn't cutting it and I don't think I am the only one. So I have my theory and am sticking to it until I hear a better one and in my opinion I haven't heard a better one yet, though Pepsiman's is compatable with mine.
Ultimately the potential of K is here regardless of this week's events and I have taken the position that this is K results or bust. So as long as you believe you have found a reason not to worry about this weeks announcements more power to you. I have mine.
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Appreciate the perspective. Possible. Definitely possibly a reason they did not feel it was essential to do it anymore. And I would add if its not essential then why take the risk if you don't need to. Dovetail of reasons in my book. Obviously agree we will never know for sure why it was cancelled. All we can do is come up with a reason that helps us sleep at night regarding why we shouldn't care/think about this turn of events as a good thing.
How are you so sure that management is so sure the drug will work? Have they said as much to you? And they did decide to cancel the PoC right? Maybe they were not as positive everything would come out perfect as you seem to be based on your own limited clinical drug experience. The risk of a mouse to human transition treatment failing is real even if you think it is unlikely. I have seen things that were 90 percent likely to work still fail. And that failure devastated the stock price even if there were other advanced trials to fall back on. Kerx is a perfect example of how one failure causes a drop whch causes a panic which causes a collapse. Five dollars to 1.50 im one day even with a drug a year away from reults that had already proven it could work. From that perspective having PoC now was simply not worth the risk.
Personally I was always in this stock for K results and PoC was just an interesting twist that became increasingly important as K trial failed to move as quickly as hoped. Part of me is glad to see it gone bc I always knew when it comes to straight up catalysts like that things can get hairy fast. I know everyone likes to believe here that management has god like qualities of infallibility when it comes to drug selection but nobody is that good. PoC could have gone against us and no telling how much damage that might have done especially given how many people would freak out that management could possibly make a mistake. So in my view this change has a silver lining and shows that management has the big picture in mind.
Now the shortest term catalysts are again all K and the focus will turn back to K on this board once the shock finally passes. K is what this stock should be all about so overall this change is a good thing. I am starting to believe Leo really is as sharp as everyone says. In some ways this is an ideal outcome for me as a long term shareholder.
Also to traders. Consider how much you could make if you had a long term tax basis in the stock and traded out only on the explosive K news and then bought back on the 40 percent dip off of that. Now that's called making money. If I trade that is going to be the moment and I only want a 15 percent charge on those gains because they are going to be big. Just another perspective on this game.
Well said.
Your logic assumes only purpose of PoC was to secure a licensing deal. Not maybe idk... to prove that the drug works to cure Psoriasis in humans before committing the funds on a larger trial. Even if you don't plan to license and even if you want to start the Ph2/3 as soon as possible (saving your months of time) you just dual track the Ph2/3 application with the PoC... YOU STILL DO THE POC!!!! A few thousand dollars in savings does not justify this change of plan!
Unless there is some other reason you don't want to do the PoC... perhaps because only short term longs benefit while the longest term of longs (the owners) don't care when exactly the P results come in. Again as the owner the decision takes the short term risk off the table which you care about in exchange for giving up a short term reward which you simply don't care much about.
Yea, seeing that estimate of 2000 patients needed to get to an NDA did not make me happy espeically with just 250 patients estimated to cost ~5M. We are going to have to spend a minimum of ~40M to get this product to market over the next 3-4 years.
With P it was so simple. Confirm it works for minimal cost and if it works spend the money to get it done with a reward of ~1B in sales. Game on.
Now we have the hard to understand decision (unless you believe management knows for sure how drugs work in humans without testing them or agree with my theory #2)to put more money at risk on P supposedly because we are too strong now (after the acquisition of a drug that is 3-4 years from market with an unknown ability to capture market share) to bother with a PoC. Give me a break!!!!
Yet if you are management and plan on holding for the end game (as ours does) then you always choose to minimize risk to the extent you aren't giving up to much. As I said from that perspective these choices go from completely insane to completely rational. Management is rational and no they do not have crystal ball that instills in them the confidence of a fool that PoC could not have failed (that's right at you Big J).
I guess the way we hope to beat the competition is by requiring potentially only one infusion of B since its not more effective than whats out there. That is still a competitive advantage and its not like the Cubicin results blew us out of the water.
Still value not clear. Cubicin captures $700M of 1.5B US market and assumption is we could only break off some percentage of that which is not very exciting. Plus TSRX's drug now also owned by Cubicin and will further fragment the market making our percentage smaller (we have no idea how this stacks up against that). At very most we seem to be looking at something like $200M in sales.
Kind of a yawn, huh...
But I guess the drug has plenty of additional uses that could generate revenue as well (like the mouthwash you mentioned). I thought that was pretty exciting sounding though no estimates on the market potential.
What's weird is the numbers on Poly's ihub site are so different (specifically better). What in the world is up with that.
Phase 2 Results - Clinical Response per Study Analysis Plan and per Protocol Patient Population
Efficacy and Sustained Response
Low Dose Middle Dose High Dose daptomycin control
Day 3 97.5% 91.4% 92.3% 91.5%
Day 7 92.5% 94.3% 97.4% 95.7%
Day 10 (for Day 3 responders) 92.3% 93.8% 100.0% 97.7%
Day 28 (for Day 10 responders) 97.2% 87.5% 100.0% 97.8%
Only a fool would not prepare for failure and as everyone is insisting management is not fools. You underestimate the impact of bad news.
Its about timing. A failure before K is proven would cut the market cap in half. A failure after K is proven may not even have an impact. Think harder :)
No trades :) Actually I think this was an extremely astute decision by management and fully makes sense from a long term perspective.
You are actually mitigating short term risk and shifting it to slightly greater long-term risk which the Company can much more easily afford to take on.
After all if K works everything else will be gravy anyway.
Respectfully I know what they said and focused on it fully. I also focused on the fact that what they said and the reason they gave did not make any sense. Of course if it does not make sense you have to look for the real reason. What doesn't add up.
Of course they would not say they abandoned PoC because of fear of failure. What CEO in their right mind would say that. Doesn't mean that isn't the real reason.
Think KarinCA!
If there is one word in the world of biotech that gets me nervous it is "confidence" without human test results that prove it already. As too many here already know "confidence" is an extremely poor substitute for test results. Those that skip them do so at their own peril (aka CLSN)
My new theory (and many here may not like this) is they didn't want to risk the share price on POC trial because god forbid it failed the SP would tank and all plans would be derailed. Solution, push out having any P results until K trial is over and results are in and for good measure also have the B study ongoing so that even if P fails to be effective, well at least you lessen the blow.
This is starting to make some sense.
God I hope the bridge is with people. That would make me soooo soooo soooooo very happy and I would take back all of my doubts in an instant. But you seem pretty sure its just another mouse study. Hopefully someone can get to the bottom of it.
Fair enough. Just lots of research on other cancer drugs and companies and clinical studies and what a skeptic needs to and does look out for when it comes to claims vs real results(namely any institutional investor). I agree we had good news that the trial was progressing rather smoothly. I just think it is important not to get ahead of ourselves.
Unfortunately I have to disagree with the extent your friend characterizes the success of the trials so far. The qualifications cannot be responsibly ignored and they were some very significant qualifications. Tumors can appear to stabilize all on their own (probably a combination of slow tumor growth and margins of error in calculating changes in tumor size which errors can be significant due to technological imaging limitations). The fact that tumor growth resumed is a clear sign that response at these levels is extremely dubious at best.
Right. We will see if we ever hit those targets at all. I have my doubts.
A drift like that seems unlikely to me unless all of the price action was due to PoC. We have additional potential having a third viable drug candidate added. We are closer to full blown p21 confirmation. The K trial will advance yet another cohort shortly. We shall see if this very real prediction holds up. Of course if you are right I will appropriately eat crow and never ever challenge you again.
However I think knowing it was falling from 2.30 which was obvious and knowing how far it will fall are two very different skills. Sept Mike made the correct call on where it would land that day. Lets see if you are right about 1.85.
Personally I am too lazy to reset my tax basis over these moves. I am letting this baby ride until march at least.