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As ususual the pphm info flow is so vague investors are left to guess at results. The 2 month margin is just that - a guess. Bavi performing as expected could easily be interrpretted as not including any margin. Dramatically outperformed coud be 12-14. The language allows for any outcome to be true: bavi slight beat, equal outcome, or control slight beat.
The story simply shifts. Now the message is that it is a good thing that it was stopped at the first look-in. PPHM can file a bla or somehow use the futility stopped data after analysis to go fda and bring bavi to market but they shouldn't. I/O is the future and Sunrise failing gives pphm a graceful way to quickly transition to I/O. And of course bavi didn't fail just the control arm over-achieved. Amazing.
Company statement would not be accurate if the control arm had in fact outperformed or even tied the Bavi arm.
The trial was stopped because bavi didn't sufficiently beat the control group. bavi could have: slightly beat, tied, or done worse than the control. Mgmt. statements are consistent with all of these - even bavi not beating control (control so outperformed it went past bavi expectations qualifies as "bavi performing as expected and control dramatically outperforming). The final resulys will like have the same impact on share price:
slight beat of soc: slight bump
tie: stock stays in channel
does worse than soc: another leg down
I really doubt they specifically address
how they plan to operate the company financially in the post Sunrise failure reality
In a trial, futility is a specific term with a known meaning. Your details are excuses/causes for how it got there.
They could however take the purely regulatory path and say: We didn't beat the control arm period and hide behind that to justify a move to I-O without any further attempt in chemo.
if you cannot get it here and there is no better treatment then people just get treated in China.
corporal, yes I have a salvaged PII showing 113% stat-sig
It is not debateable whether Sunrise was stopped for futility. This an undeniable fact. No additional info needed. Do you understand that the definition of a trial stopped for not exceeding the control is futility?
Remember this: Flipped PS is universal and universal targeting of PS is a quick and easy add-on combo therapy or I should say will be exactly what makes immunotherapy.... IMMUNOTHERAPY
clearly people selling pphmp to buy pphm .... deal on way
Probably the biggest change in the landscape since we started enrollment is the approval of checkpoint inhibitors in this space, and we probably have patients that have received checkpoint therapy, and if there's an imbalance between the 2 arms of the study the subgroup analysis should account for that.
MSK and NCCN, besides AstraZeneca, are now ALSO involved in setting out a pathway for bavituximab. A strange and in my opinion stupid effort for a drug that so many claim doesn't work. You'd think they have better things to do at MSK, NCCN and AZ then playing kindergarten with PPHM, wouldn't they?
hmmm, "We have a shortage of buyers, no one believes our story after our trial failed. Can you please make these pesky shorts go away so we can find some new investors and raise our share price towards compliance." Something like that?
The only thing I fault them for (aside from poor communication- which may be due to part of their being naive to think it would help) is thinking BP and the FDA were going to let them come in ( as small as they all are in wealth) and turn the bio world on its end with bavi.
I further understand this management team is making a large sum of money for their worth but I also understand and have seen such management teams vanish under certain conditions.
As explained before I see SUNRISE stopping as a DELAY to market for Bavituximab not as a change of value.
Lol ...rs split is neutral, pphm value not reduced by Sunrise failure. I am trying to say that without laughing but can not.
That is totally misleading of course the rs at the instant it happens is MATHMETICALLY neutral and of course for the company reputation, shareholders, employee moral it is a disaster - far from neutral.
No faith in mgmt but never did. Some hope shareprice gets back to $1.00 (split adjusted - don't see the rs being avoided)
It was a bad loan because of the t's&c's, certs&reps, penalties etc. they agreed to. Just like the csm contract that had way too little protection for the dose switching. pphm can not negotiate a contract or put in place proper coverage for the risks they take. Terrible business-people.
... I already gave my opinion on a reverse split.
It is neither good nor bad. It is neutral.
It is what happens AFTER a reverse split that matters. If at that moment you do not have a price support then the increased, PPS due to the split, leaves more room to be shorted down.
It is what happens AFTER a reverse split that matters. If at that moment you do not have a price support then the increased, PPS due to the split, leaves more room to be shorted down.
We have no idea what exactly they negotiated but PPHM was prepared for this and had inked down the possibility and therefore also : what happens when that happens.
Lack of evidence that it was a crime not error.
Chemo is not going away in the next decade. If bavi worked better than soc they would continue chemo/bavi.
Am I even close to thinking 10x earnings going forward might be a reasonable assumption? I've lost my handle on what earnings may be. Would appreciate help with getting a number more pinned down.
Since pphm is the very kind of stock he would never buy the rest would seem to not apply
While on here some cannot see that difference the industry does
Little problem ......IT DOESN't WOEK.
It is simple to see that Peregrine can file a BLA based on the statistically significant Bavituximab portion of Sunrise,
geocappy, I am sure of it. No Eastern, Blackrock or alike will go for that change. It is not what they invested in and it is not because some on here do not believe in the PPHM part of PPHM/Avid that the informed world doesn't.
All people that UNDERSTANDS what it means : Stopped because the control arm outperformed.
technically Bavi didn't make the end-points.
It is therefore not impossible that while we think that there is insufficient data to successfully file for a BLA in this study, PPHM files anyway
clearly within the context that PPHM should not be doing a PIII but was outside its will FORCED into one because the FDA licensed our CRO
In other words: SUNRISE was DESIGNED with an OUTPERFORMING CONTROL ARM as part of the possibilities and has PROVISIONS for it.
I do not EXCLUDE the BLA. ... I'd prefer that they DO NOT file BLAs based on CHEMO combo's. But that is my PERSONAL OPINION because I am NOT short of time and prefer the IMO bigger potential of I-O alone then the short term CHEMO potential
really wrong of you to be suggesting there is a secret BLA going on here. That is a <1% likelihood. Add that to your representation of the trial as simply a misinterpretation of the futility stop, and Sunrise proves bavi works ...
Reasonable Investor is the benchmark for SEC 10-B5 and things like what is material info etc. In this case alleged to demonstrate pphm harmed investors.
It was an awful presentation by plaintiff. Basically he is pinning his case on the word, "transformational" in the press release. Claims that word mislead investors because pphm had not independently verified the data. Then he goes on to agree that there is no requirement for such a review before announcing data results from CRM. Of course you never know with judges/trials but very, very, weak arguments and no support from judges and more importantly no queries to pphm lawyer from judges.
sorry I simply sad that no one new her motive, but no proof some huge conspiracy to keep bavi the wonder-drug from coming to market. Sunrise pretty much solidified that position as correct.
By the way, have you noticed we were there in Q4/2011-Q1/2012 too
By the way. Have you noticed the stock is totally broken? That the share price s $.35? That a RS is a high high probability? That pphm is being booted from Russel? To be representing that the trial was just a misinterpretation and shows bavi works, that pphm is not a failed state at this point, in a disastrous situation; that's very misleading.
Yes they have Avis but little else. And shareholders, in an uncharacteristic method for a mfg company, paid for the plants (ATM sales are rarely/never used for mfg co's). Shareholders are right to demand that pphm not squander what is currently their only asset.
Furthermore they would loose control 100%. A party that would buy more then 15% will NEVER EVER accept to have those shares without the voting power that comes with them being 'veto-ot' by the poison pill.