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PPHM always a good time to buy at a bargain, and sell at a loss.
I wouldn't be surprised if that last 10% takes another year to get done. It's the PPHM way. Delay delay delay preclinical exciting data delay delay preclinical exciting data repeat as unnecessary. Considering that Bavi data has never been unequivocal it is highly unlikely that any early look in would lead to anything other than obfuscation.
PPHM was naive? uh. SK has made millions from PPHM prior to this. so millions buys naive? that's not exactly a great endorsement.
the FDA let this trial go ahead cause although Bavi doesn't appear to work it doesn't appear to do harm. You think it's OK that PPHM went from combining the 1 and 3 mg/kg and then turned around and combined placebo and 1 mg/kg?
so 3 mg/kg was less than 13.1 MOS? and a 1 mg/kg that may have been mixed with placebo was greater than 13.1? defies common sense.
The only false information is the duplicitous nature of PPHM management who have taken you shareholders on a steady downward slide while enriching themselves.
Don't worry- when it all comes crashing down I won't say I told you so.
if it is so obvious CSM "sabotaged PPHM where is the big cash payment they are making to PPHM? It's been enough years. Answer- there isn't going to be one cause it wasn't CSM's fault. The people at fault were PPHM's team who thought they could do a blinded study but know the answers so they were censoring the wrong patients. Boy they got a surprise when they're cooked up numbers blew up in their face. Check it out. Look at all the PR's about this. The placebo and 1 mg/ kg bave were switched but that meant that the first numbers PPHM reported 5.6 month MOS for the placebo were actually for Bavi! How come the MOS for the 3 mg/kg changed as well going from 13.1 months to 11.7 months in that heavily censored arms.
No sabotage- Bavi doesn't work
Only PPHMers think Big Pharma is out to get them. Every other Biotech knows Big Pharma needs new products and will overpay for one. And for the Biotech they get to see their drug make it to market. Do you think Inhibitex hates Big Pharma- BMS paid billions for a drug that didn't work and wrote it off. If you do some research you will find many examples of billion dollar deals for products that don't pan out.
The fact that PPHM cannot entice any Big Pharma to buy them or invest in them speaks volumes.
See when Big Pharma goes in they have the appropriate people with the appropriate education and experience level to really look at a program. They cannot be swayed by BS from a Biology major from Texas Tech.
If Big Pharma is sabotaging PPHM which one is the culprit? If PPHM had a miracle drug there would be a bidding war. all you need to know is that there is not one and every Big Pharam has kicked PPHM's tires.
The fact is PPHM will pump up things that aren't really worthy of being pumped up. It is truly miraculous that PPHM was able to get a Phase III trial but the reasons are the indication and that Bavi at the least will not kill a cancer patient. That said this is about a small Phase II study as you can get, the Phase II botched trial was overly censored. They won't be able to do that in Phase III. The level of scutiny will be greater and they won't be able to say things like trends, or we combined the placebo and the 1 mg/kg dose.
The track record is one of deception, overpromising and underdelivering
a normal biotech would be more than happy to exit. Of course those are ones run by VC who want their money back. SK and the board control your money and they don't care if you get it back or not.
Realistically, if you have a drug that works you need to have a big company make it, market it, and distribute it. A small company simply does not have the capabilities to do that. Big pharma and biotech overpay for new drugs- look at the deals that are going around.
currently the only PPHM phase III trial is for second line with falling out of favor fast chemo. That means PPHM can only market for the dwindling second line market with is way less than a billion.
The combos are completely unnecessary and misleading. The real checkpoint inhibitors do fine on their own without the "help" of Bavi.
PPHM is running out of shares to even do an ATM. At these prices and their burn the clock is ticking, PPHM will not even have the resources to do yet another phase II where there is "positive" data, a trend which is consistent with other trends yada yada yada. The only consistency I see I SK putting lipstick on a pig.
the only thing SK knows is that he is getting paid a lot at PPHM and can never hope to get anything remotely close to that situation in another company.
Seriously suppose PPHM went under (which of course is only a matter of time) what company is going to say- let's get SK for his expertise in bringing a drug to market and being a dynamic leader? It's not going to happen. Then look at the rest of the leadership- same thing. And yet no matter how low the share price goes, how little PPHM says that comes true, the truck is always being backed up to buy PPHM at these great prices.
It's a little bit more than 21 months. Bavi's been around for years multiple trials, never worked frontline, old chimeric technology, company run by amateurs. Just cause the price is low doesn't mean it's a bargain. They're still going to use the ATM even at these prices.
Bavi doesn't work- it's that simple. When the charade is over you will finally see how SK took you to the cleaners.
The next time SK tells the truth will be the first. The broke shareholders have made it possible for him to retire when PPHM runs out of ATM shares.
what they know is that they will never pony up money for PPHM. PPHM will dilute and pay them off for what amounts to nothing more than a high priced PR.
Does PPHM honestly need yet another Phase I to determine safety?
The thing about PPHM- it's always the right time to buy and never the right time to sell. With the massive amount of dilution, a fall in the share price is inevitable.
It's a shame no one ever answered my question about other proteins that bind PS, how since bavi binds to beta 2 glycoprotein, an abundant serum protein it would not be effectively diluted by it, and how come bavi, despite all the hype, has never been effective as a frontline treatment.
hopefully PPHM has signed up enough patients so they can censor the heck out of them and still come up with mediocre results.
One good thing about Bavi- it doesn't do any good but like most antibodies it doesn't have a lot of side effects. That is why it was greenlighted.
Since PPHM has started trials of Bavi the following have happened- approval of EGFR inhibitor, approval of ALK, approval of PD-1 inhibitors, use of Avastin with carboplatin or paclitaxel for starters.
here's a good one- Bavi is no better than palliative care-
In a 2010 study of patients with metastatic non–small-cell lung cancer, "early palliative care led to significant improvements in both quality of life and mood. As compared with patients receiving standard care, patients receiving early palliative care had less aggressive care at the end of life but longer survival" which was increased by approximately 3 months
I'm glad you're getting a good laugh. SK is also getting a good laugh with your money.
It doesn't mean anything other than false hopes. Baci never has shown unequivocal reresults. Any positive result is accomplished by heavy manipulation of data, something that is hard to do at first look in
sure Biopharm I would be happy to-
Is the MOA the one from 2004 when it was anti-angiogenic, or the one that says it doesn't work as a frontline therapeutic but works best with Docetaxil and not other chemotherapies, or is it the one that says it changes the microenvironment of a tumor and even though it still doesn't work frontline it works great with PD-1 inhibitors.
There are at least 3 MOA's for Bavi and miraculously it changes according to the state of the art. It is never ahead of the curve only behind.
Or are we talking about the MOA of Bavi's greaet anti-viral activity that 4 years ago SK was saying the time was right for collaboration with Big Pharma cause bavi was a broad spectrum anti-viral
Here's the problem as I see it. bavi does not directly bind PS, it binds Beta 2 glycoprotein that binds PS. PPHM never likes to tell you that. Why not? cause there are other proteins that bind PS as well. But wait a minute, isn't the whole point of bavi is to cover up the PS so it is no longer able to signal? What does it mean that CD300 also binds PS.
And here's the biggest problem. PS is exposed on cells that are already dying. They don't need any help in that regard and are not going to do any more damage. So bavi binds to cells that will not continue to grow. How does that help destroy a tumor?
PPHM is completely irrelevant to Calico. It is pretty clear what the mission of Calico is and it does not include PPHM.
When Calico has a product you can be sure if PPHM is still around ( which it won't be) that Steve King will be saying it is more active with Bavi
absolutely run differently. the people at the top of this company would not be able to work in anything but an extremely junior level position if at all in a legitimate pharma or biotech. They are grossly undereducated/ experienced/ accomplished for the enormous compensation they are receiving.
King/Lytle/Shan-
0 experience at a Fortune 500
0 accomplishments ( unless you consider fleecing shareholders an accomplishment)
Someone just threw a penalty flag!
That's a personal foul, 15 yards for excessive use of the word "promising"
another 15 tacked on for overuse of "encouraging"!
here's some questions I've never seen answered here
where do Avid's revenues come from?
who are their clients?
is one of their clients PPHM?
Is PPHM selling at the ATM so it can then pay Avid for making PPHM products?
What would Avid's revenues be without PPHM?
got many more questions like, what is the point of reporting EPS when you dilute. Of course you're going to have less of a loss per share cause there's many more shares!
the problem with trying to sell a multitude of small studies with "trends" and "consistent with" to pharma is that they know what a trial should look like. They're doing trials with thousands of patients that have statistical merit. Hard to believe PPHM could pass off their inconclusive trials as something worthy of a multimillion/ billion dollar investment. Which is not to say that big pharma can't be hoodwinked. Consider Jeff Hutchins last company Inhibitex- they got BMS to pay 2.5 billion for a worthless drug. PPHMers that is your only hope.
if it makes you feel better to think that go ahead. But the way I look at it PPHM needs to report something positive every once in a while and so pays a little to play with MSK. It's a big place and people aren't above taking money for nothing.
bingo
this is a modestly costed PR stunt.
that's a sensible way to pick a stock. SUNRISE will be PPHM's sunset, a nice trip into a fully funded retirement for SK and his gang that can't shoot straight, while the shareholders end up with less than nothing.
allegedly extending life a few weeks is nothing close to a cure. compare to the PD-1 inhibitors that melt tumors away. There has never been a case of Bavi melting anything away other the share price.
it works better than docetaxel. Bavi only allegedly works with doxetaxel. It's a no brainer to not take chemo when you dont' have to.
if there is such a large patient pool why do you need so many sites?
I do agree it won't make much of a difference in the already struggling enrollment.
you don't know how PPHM "discovered" it. In the few things they said about it they never mentioned that they discovered it using blood tests.
If they had been regularly doing blood tests they would have noticed the problem immediately.
No one switched doses, CSM properly labelled as they saw fit to ensure it was a blinded study. PPHM were the only ones in way over their heads.
Mary Boyd is actually the most qualified and well educated person PPHM has. If everyone working for PPHM had her experience things would have probably turned out differently
with PPHM anything is possible, even things that defy the rule of logic ( and statistics)
158 sites for 600 patients is setting a world record for inefficiency. It probably is the worst way possible to run a trial. Less than 4 patients per site? Taking 2 years to enroll. that's 1 patient every 6 months? Sounds awful.
I used to think that PPF but I've come to the conclusion that I have been mistaken and quite frankly stupid to not recognize the top management skills of the PPHM leaders. I have also not given Bavi it's due. To say it is a miracle drug would be a gigantic slight.
I have seen the light- time to back up the truck!
first off it was A B C as proposed by PPHM and B A C as labelled by CSM.
PPHM should know that if you are doing a blinded study you don't get to know what is being labelled what . That is the whole point. PPHM cannot tell CSM how they want things to be. You do the study then you unblind.
PPHM was trying to work the data before unblinding assuming they knew what A B and C were.
Let's recap
When PPHM first reported the Phase !! results
A= 5.6 MOS
B=11.7 MOS
C=12.1 MOS
What a moment when they realized the real results were
Placebo 11.7 MOS
1 mg/kg 5.6 MOS
3 mg/kg 12.1 MOS
I would bet any amount of money CSM will not pay PPHM anything and PPHM will pay CSM to make the whole thing go away. What's taking so long is that PPHM is trying to figure out how to PR this disaster and make it look "promising" and "encouraging".
The mistake PPHM made was assuming the the control, 1mg and 3 mg were labelled A B C. So PPHM started getting data about A B and C and started getting all excited cause B was doing great. When they finally realized that B was not 1 mg/kg but control they panicked. If you recall originally they combined the 1 and 3 mg arms to try and get something they claimed had statistical significance. Now they are combining control and 1 to cover up the fact that the control had a better MOS than 1 mg/kg.
According to the statement CSM would be the ones who decide what is A B and C. This makes a whole lot of sense as that really blinds the study.
Again you have tremendously inexperienced people on PPHM's part running this study. Combine that with PPHM's lack of integrity and you have the toxic mix that left a big mess.
this is what I have maintained all along. PPHM thought the vials would be labelled A B C but were instead labelled B A C. According to PPHM initially B= 12.1 MOS, A 5.6 C = 11.7. That meant the best response in the entire study was from the placebo. That means Bavi doesn't work.
So PPHM combined B and A to make a fake MOS less than 11.7.
There was no dose switching.
Incompetence from Leyco- who probably had never done a double blind study or Shan under the management of the woefully incompetent SK.
If this ain't a mess it will do until the real on gets here.
the article says that CD300 helps phagocytosis which is the opposite of immunosuppression.
did they mention the non-responders turning into responders was in a rodent? Do you have any idea how many cancers have been cured in mice? This is debatable pre-clinical data.
If you have followed PPHM you will know they put the best spin they can on the smallest amount of tortured-to-make-it-look-positive data.
You will also know they don't do their due diligence which is why they completely botched their Phase II.
Even a hick shouldn't buy a pig in a poke.
How anyone can believe a word they say after all this time is beyond my understanding.
not nearly as much as you think. due to massive dilution this stock cannot increase very much. They fast tracked to a 2nd line indication. That is all they will have available. 2nd line is a small market and with all the new drugs getting approval that small slice of the pie is smaller every day.
why would you need 150 sites for 600 patients? None of these sites are at major state of the art cancer centers. Kind of sad.
it is easily argued there are no damages.
1) as many here have said the FDA approved Phase III so the alleged mixup didn't stop that
2) it is likely that PPHM botched the vial situation. It is a matter of record that PPHM wanted the A B and C groups to be placebo, 1 mg/kg and 3 mg/kg. Guess what, the whole purpose of a double blind study is that nobody knows what is being given. It was perfectly correct for CSM to label anyway they saw fit. Only PPHM assumed that A B and C were what they wanted. and as they cooked up the data and the censored patients before the unblinding they never figured out that the worst outcome was 1 mg/kg and that the placebo and the 3 mg/kg were nearly identical in MOS.
bottom line- PPHM does not understand what a double blind study is.
I'll take some of that. All you got.
I see the future- a preclinical study by PPHM showing encouraging results in combination therapy with Bavi and (fill in the hot therapy here).
you would have to ask the hundreds of other who worked on the approvals starting from the scientists who discovered the drug, to the manufacturing unit that made it, to the clinicians who tested it and to all the people that they needed to make it a success exactly what part regulatory played.