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There are many things that are worth studying that does not mean that a small company with limited resources should do that.
The fastest way for PPHM to succeed is by a successful Phase III with Bavi. Of course if the Phase III fails PPHM is done. That is a risk but if you truly believe you have a wonder drug you go for it.
Preclinical combination therapy is a distraction.
On a technical note I did not say murine Bavi would not play well with the other combinations. I said when you do an experiment in a murine system you need murine reagents. I don't know how PPHM would obtain anti-PD1 antibodies in the first place and don't know how they would be able to obtain the murine versions of these to actually do an experiment.
I also am unclear what advantage other companies would have to just try out and see if their therapies work with Bavi. Anti PD1 seems to be doing great on its own. SInce it works on its own there is no need to combine it with Bavi. And considering PPHM screwed up the last trial it did if I was in BP I would not want PPHM touching my therapies in anyway for fear they would mess it up.
So I read my own tea leaves. When management is talking about anything other than Bavi Phase III it means they are unsure of the Phase III.
Successful Phase III will bring the most value to the shareholders. Preclinical data that allows SK and company to keep their fat paychecks benefits them not you.
preclinical means non-human you know. In order to test the other therapies in combination with Bavi they would have to somehow obtain the murine versions of anti-PD-1 etc. Don't really know how they are going to do that and if you use the human version the mice will have an immune response to it to cloud your results.
And besides it's preclinical!! do you know how many times cancer has been cured in mice?
They had a chance to show something in the Phase II trial. We do not even know what 1 mg/kg does . That is pretty important information to not obtain.
When you have things going into Phase III you should not be touting preclinical. Makes it seems like you don't really have a handle on what is going on and are trying to manufacture excitement.
Even if they have a new MOA for Bavi it begs the question of how come we don't see this great effect in the clinic that you see in mice.
$60 million
A lot especially since MLV takes a percentage of proceeds
I think they might have @140 million or so more shares to sell but who in their right mind would but the last share knowing they're running out of funding
What a waste that Sydney trip was. Probably cost as much as one full time PhD to generate data for and entire year. What is the point of "getting the word out" if there is just stale data regurgitated.
And does anyone know who went. Did SK go? Who else? Hope they had fun.
At this point all of BP has heard of Peregrine. Everyone is interested in NSCLC. Are they interested in something that only works in 2nd line as Bavi does? Probably not.
GLTA well meaning investors but you're not going to get rich off of PPHM, it is not the next Genentech or Amgen.
There are biotechs out there that are worth investing in. Let go of the PPHM fantasy. When you pull back the curtain there is nothing there.
let's stick with the facts
Bavi has never had an unequivocally successful trial phase I II or otherwise. It is safe but so is a sugar pill. There are only promising, exciting, showing trend, leaning towards type data.
Upper management has zero experience exiting. You can find biotech veterans with serial successes developing and selling companies. You cannot find one of those at PPHM
Bavi started as an anti-angiogenic now it has morphed into an immunotherapy. Every conference call brings the idea of exciting possibilities. How about a conference call that provides direction and shows PPHM consistently sticking to that script instead of making it up as they go along. One CC, emphasize Cotara, next Bavi in pancreatic cancer, then Bavi in breast cancer, then imaging, then Avid then lather rinse and repeat. Then bring in Brekken,
Getting the word out is not what a company with a real pharmaceutical does or has to do. BP does not sit around and say we have to suppress Bavi cause it will put us out of business.
BP does say, oh yeah, I heard of that company, they screwed up their trial. Not sure how an antibody to a structural phospholipid would work. The antibody isn't even to the lipid is it. It's to beta-glycoprotein. Interesting, think I'll pass on it. ( they are usually polite).
The company does spend a lot of money on upper management, conferences and symposia. This money would be much better spent on science, upgrading equipment, hiring scientific talent etc.
Bavi is years away from approval and they don't have the money to get there, especially when a sizeable amount of the ATM goes to paying SK and his friends.
So although Garnick allegedly participated in at least 17 trials at a big biotech he thinks they have less expertise than PPHM doing their first Phase III. This doesn't pass the smell test and is a complete 180 from previous thinking. It amazes ne that they can say this stuff that not only flies in the face of logic but contradicts their own statements
You got a candid answer from Hutchins. He said they never applied for BTD for which he will probably be taken to the woodshed as honesty is not the PPHM way. BTD means you can get approval faster. There is no company in the world that would not want approval as early as possible. There is also no small biotech that would not want to harness the power of a large company in development of their therapy.
I found SK's rambling remarks about potential collaborations particularly troubling. Where is the focus? With finances limited due to the Phase III you cannot be all over the map. There is a disturbing lack of focus. What is needed is clear-- a successful Phase III ASAP- not revising the MOA or doing experimental combinations with experimental therapies.
for a small company like PPHM it is ludicrous to think they can generate enough conclusive data with that many combinations. Each combination would require different combinations presumably to find the optimal one. The big problem is when you have a "global upstream checkpoint" you shouldn't need to worry about the downstream. Why doesn't Bavi work frontline unassisted if immunosuppression by PS was a major player? Maybe it really isn't.
that's the problem with PPHM. they should worry about having a high quality product. Instead, they intimate that anti-PS will be worth billions (wishful thinking that should not be taken seriously). The fundamental question is if Bavi is such a great upstream inhibitor why do you need a downstream partner therapy and why doesn't it work much better than has been shown so far.
you heard it here first.
PPHM will not exist in three years. The ATM will run out, there will be an incomplete Phase III, and that will be that. Expect more deceptive CCs in the coming years explaining why the enrollment is slow and touting potential collaborations that never occur. Think to yourself why anyone would collaborate with PPHM. Anything PPHM can do BP can do better. The qualifications of anyone working in BP are solid, people can succeed in PPHM with little credibility and qualifications. If you want to invest in a company that is really trying to do something about cancer look elsewhere.
You're going to get Hutchins in trouble.
Here's what I see- Bavi supposedly will be worth billions, everything else is not worth discussing I.e. Cotara and Avid any more than in passing. The fact that King spent so much time discussing them shows there is no real progress with Bavi. This CC should have been almost exclusively on the start of the Bavi Phase III and the progress towards that. After talking up AA they now discount it. And then Brekken? On an quarterly call? Just a distraction and I'm sure they paid him plenty so you don't think about the three to five years it will take for the Phase III. A lot of smoke and mirrors cause there is no partner and the Phase III will not start in time
what a complete joke. that's life in the big city SK, when you run a company into the ground the stock goes down. nice to have a BOD to reward you even when you haven't done your job.
wouldn't it be nice if PPHM cared this much about the shareholders
And the arranger gets a nice cut of the proceeds. And you wonder why they lob softballs at the CC?
When you consider how much it costs PPHM to defend lawsuits, how much they pay upper management (garnick's pay is not reported but could be as much as $500000 or even more), plus the fees from the ATM and travel to symposia all over the world- where is the money to generate data? Where is the money to fully fund the Phase III?
Possible synergies are not determined in a booth in Sydney but in real lab producing real reproducible results. I think technically it will be very difficult to conclusively demonstrate real synergies. I will wait until another lab reproduces the upstream checkpoint theory. As with most experiments there are multiple interpretations of data. PPHM picks the theory that helps them the most not necessarily the one that makes the most sense
all this talk of "partnering" has me wondering what PPHM would bring to the table besides Bavi. There is no reason for a BP to "partner" with PPHM as once they obtain the rights to Bavi there is absolutely nothing PPHM could do to help them. They certainly would have absolutely no need for the entirety of upper management.
Why does Garnick not mention his association with PPHM on his company website? He is a well paid consultant. It is actually disingenuous to describe him otherwise.
Until immunotherapy became hot Bavi was an anti angiogenic. Step right up, Bavi can be whatever you want it to be and works with anything. All you need is wait there's more. PPHM are more hucksters than scientists
They wont answer that question, You will get the same response from King that they are in discussions, that there is interest but they can do the Phase III by themselves. What you will hear will be an overreach concerning upstream and downstream synergies (that sounds good doesn't it but don't put any stock in preclinical total of one, thats right, one paper). I see they are dragging out the poster for Australia showing how they combined the two arms. IMO no self-respecting biotech or BP would think that was anything other than amateurish and non-sensical. You have already heard what they will say.
Remember no small cap company has ever had a successful Phase III for cancer. From your list selling the rights to Bavi is the best thing to hope for and best for shareholders as some may get a modest profit. My prediction is there is no pot of gold at the end of the PPHM rainbow
If the phase III is supposed to start soon these positions should not be for that unless PPHM is not ready for the Phase III. What is the consensus for what starts a trial 1, 10, or 100 patients enrolled?
Does anyone know how much Avid contributes to the bottom line? If they are burning $7 million a quarter that would mean that if Avid is self sufficient PPHM is using a lot of cash. Too much cash for a biotech in their position.
Deals do not get made in ballrooms or booths. It is done by people who know people in the business. SK has experience presenting in front of financial groups but has no experience working with others in biotech. His lack of connections is holding back PPHM
really? you know how they determined who got what dose? and what the schedule of each was? please let me know I have not seen that.
If I recall correctly PPHM said they would get a third party to find out what caused the mixup. What happened to that idea? Maybe they realized they screwed up the vials.
Out of the 40 patients in the Bavi phase II 3mg/kg arm how many responded?
In PPHM logic that means SK is 20x better
A job well done is twice done
If this gold standard Phase II was a success, what would a failure be?
We don't know what the effect of a 1mg/kg dose is. Wasn't that one of the points of the trial?
How do you justify a 3mg/kg dose other than that arm didn't get screwed up?
What they should have done is repeat the trial asap. It would be halfway done by now.if the data looked good they would have a partner and a shot at btd.
GJH seems about the fairest person on this board. I am not since I obviously do not care one whit for the way PPHM is run. If Bavi works would you not want the strongest team possible promoting and advancing it. When you hear SK do his CC talking to only organizations that have a financial vested interest in saying nice things about PPHM i,e, MLV, etc, does that get you fired up? Does hearing how excited they are about pre-clinical data do it for you? Do you feel good knowing that a small cap company has never successfully brought a cancer drug to market?
IMO if Bavi is to succeed it will not be done by SK and company. They need to go ASAP and get someone in who actually knows and understands biotech. That would drive the share price up. You see, I'm trying to make more money for you not less.
HACA not HAMA
I don't think Thorpe was cited enough to be in contention for a Nobel.
I do enjoy everyone's insane fealty to this company
so Jeff Hutchins is an expert on PS after being there all of one year? Or is he just a nice talking head.
Do you mean fully human? Or humanized?
doesn't really matter lowering seroconversion is a good thing. It means the body is not developing antibodies to the fully human/ humanized antibody
do you know what HACA is?
how many companies are currently developing chimeric antibodies?
I want to see patients get drugs that will actually do something for them.
So far the evidence is far from convincing that Bavi really works.
Bavi is safe that is why it was approved for Phase III. Now all Peregrine has to do is convince patients that from among all the other Phase III drugs out there that Bavi is better. And I don't think the argument is compelling to doctors who are trying their best to save peoples lives and may look at things a little more critically that all those longs who are holding on in the hopes that one day they will hit a jackpot.
if management team makes no difference then why are you paying them so much money.
Let me see, chimeric antibody ( that means it ain't fully human) to a structural element of a cell that already binds other proteins. No successful phase II
Or cutting edge technology to a well understood target ( IL-6R).
Is it even close?
maybe selling a company for $500 million was not the right thing to do but he got the deal done, something King has not been able to deliver.
Zuckerberg and Jobs were not employees they were entrepeneurs who created great value.
If you're happy with PPHM management great. I'm sure they love people who are not critical of them and who enable them to keep being rewarded for incompetence.
IFU
do you want me to go through the other members of the management team? It ain't very pretty
Their CFO has an MBA and experience at a variety of companies. PPHM-- cal state long beach accountant and PPHM is his only experience
CMO-- they have one does PPHM?
COO-- Medical doctor who has worked and Fortune 500 companies and lectures at a university.
No problem. Just look on their website. Here's their CEO. Edwin Moses
Chief Executive Officer and Chairman of the Board
Notice he sits on other boards-- does King? No
He has actually worked at other companies. King? PPHM lifer
He sold a company for @500 million. King? No
He is also Chairman of a health tech fund. King? No
Here's his bio
After completing his post-doctoral research in Germany, Edwin Moses began a commercial career with successful periods spent at Amersham International, Enzymatix and Raggio-Italgene. From 1993-2001, first as CEO and later as Chairman, he was responsible for the growth of Oxford Asymmetry (OAI) through a series of venture rounds cumulating in a flotation (LSE) in 1998 at a value of £120 million. This was followed by a sale of the company to Evotec Biosystems in 2000 for £316 million. During this period, OAI grew from four people to over 250. Over the past eight years, Edwin has played an important role at Board level (primarily as Chairman) in over 15 European life science companies. During this time he has been involved in a number of financing rounds, a series of M&A transactions and four IPOs. He has been Chairman of Ablynx since 2004, and in 2006 he accepted the offer by Ablynx’s Board of Directors to extend his role as Chairman to include that of Chief Executive Officer.
Apart from and in addition to his duties as CEO and Chairman of the Company, Edwin Moses is the Chairman of the Board of Capricorn Health-tech Fund (Belgium).
Furthermore, in addition to Ablynx, he has held Board memberships with the following companies: Clinphone Group plc (UK), Fusion IP plc (formerly Biofusion plc) (UK), Phoqus Pharmaceuticals Ltd (UK), Pharmaceutical Profiles Ltd (UK), Proimmune Ltd (UK), Paradigm Therapeutics Ltd (UK), Avantium Technologies (the Netherlands), Ionix Pharmaceuticals Ltd (UK), Evotec OAI AG (Germany), Bioimage A/S (Denmark), Inpharmatica Ltd (UK), Prolysis Ltd (UK), ProPharma Ltd (UK), Lectus Therapeutics Ltd. (UK) and the European Biopharmaceutical Enterprises.
Dew makes one entirely inarguable point and y'all jump all over him.
Look at the company Ablynx that Abbvie just did a deal with. Look at their management team and tell me with a straight face that the PPHM management team is on their level.
PPHM is responsible for every aspect of a clinical trial. If you can't stand the heat stay out of the kitchen
how many times has that vendor done double blind studies. a lot
how many times has PPHM done double blind? first time
who is more likely to have made a mistake?
I can very easily see PPHM blaming someone else for their own mistake.
cause what they are trying to do with that trial is just bad business.
I am not convinced that it wasn't PPHM that screwed up the samples that were then labelled apparently incorrectly but who knows.
If the vendor screwed up how come there is not a settlement at this point?
The rules of the FDA say no ad hoc revision to a trial protocol after it has been completed yet this is exactly what PPHM is doing.
So until we know what really happened consider it botched.
Don't shoot the messenger.
why on earth would Allergan want anything to do with Avid? Avid is not on the cutting edge of anything. All that money SK and his cronies took rather than investing in the company is the reason.