Right on, Couch. Many Sunrise patients have been treated. Many Sunrise patients have completed initial treatment.

This train is running down the track as fast as 155 worldwide sites can push it. Success is not certain. One thing is certain. Peregrine 2015 is not Peregrine pre-2014. The company has pushed all its chips into the pot. Go big or go home.

We'll see in a matter of months which way this breaks.

GLTA, Paul

CP, please don't confuse the debate with facts. Some don't find a fact based discussion satisfying.

GTLA, Paul

TOG, calling King inept when he has focused the company on Bavi, saved the sabotaged Phase II 2nd line nsclc trial, minimized the dilution through the new share class, pushed Sunrise to 150 plus world wide sites and moved Bavi into dozens of collaborations in the promising immune therapies, seem a little harsh.

GLTA, Paul

Hypi, as many have noted the Sunrise look-in triggers were revealed. Don't see how you missed something so important. It was on the slide show.

As to the share drop when the CEO spoke, not fun to watch. However, the hot money that flowed into PPHM over the last week flowed out. Obviously, these players hoped for a quick score on some surprise news. Didn't happen, so they took their money to the next play. Nothing to do with SK's talk in my view.

GLTA, Paul

Sunrise news to me.I see from King's presentation that the early look-in triggers are 33% evented and 50% evented. Didn't know that before.

If we have to wait till for the 33% to event, we need about 190 or so patients to expire. Gruesome to think in these terms. When might that be?

To complete Sunrise enrollment on schedule, the average rate of enrollment is about 30/month from June of 2014. After roughly seven months SOC patients start to die. After roughly 11 months Bavi patients start to expire.

January thru April 2015, 15 SOC patients per month event, or a total of 60. From roughly May 2015 on, 15 patients from both cohorts or 30 patients per month event. So, events approach 190 or the 33% point around September 2015.

Now I believe the DMC is monitoring Sunrise continuously; so, they may suggest Peregrine stop the trial at any time for good or bad reasons. If they don't, we won't see any news from the trial until September or so. I hope for the trial patients and ourselves the data is so good we don't have to wait that long.

GLTA, Paul

edcpf, I think early approval is possible based on the strong Phase II study survival data and Garnick's statement that the 120 patient Phase II study was statistically significant. It seems to me that Sunrise might process 120 patients to the point of determining overall survival before the end of 2015.

Survival of 11 months would meet the trial objective of a 40% increase over the 7 months under the SOC. Backdating 11 months from November of 2015 take us to January of 2015. Remember Sunrise had 25 sites open in May of 2014, and over 100 sites by December. Could Sunrise have started treatment of 120 patients by the end of 2014? Average 15 patients a month for 8 months to reach 120 by January 1 of 2015.

Statistically significant improvement in overall survival for a patient group like 2nd line NSCLC could get fast action by the FDA.

I'm not suggesting that the above scenario is probable. However, it does seem possible to me.

GLTA, Paul

geocappy1, I too would be shocked if Bavi got approved this year. Not because of any bias in the FDA. I just don't know that the data could support such a wonderful result at this stage of the trial. However, I do not consider it impossible.

Obviously there is a very cozy relationship between the FDA and BPs, but I doubt the FDA would deprive cancer patients of desperately needed relief.

GLTA, Paul

pdb, who knows what may come out of the CSM litigation.

What we do know is that Peregrine's fortune will be determined by the Sunrise pivotal Phase III trial .

The Sunrise trial you may recall is a worldwide trial at 155 sites. Twenty five US sites have been open since May of last year. That would be ten plus months. The initial treatment plan is twelve weeks. Who knows how many patients have already completed treatment?

The trial protocol calls for two early look-ins to be overseen by a Data Monitoring Committee. Exciting to think great data from the trial, which many of us expect, could cause the DMC to halt the trial recommending Bavi approval to the FDA. Maybe this year.

I am probably too optimistic. However, early Bavi approval would be very good news to 2nd line lung cancer patients and wouldn't hurt those of us who hold PPHM shares.

GLTA, Paul

Verylong, with your point of view I don't see how you will ever anticipate any moves up.

Many of us do see the Peregrine glass as more than half-full and expect more good news to keep filling the glass on a regular basis until blow out data from the Sunrise Phase III trial moves us well above the current level.

GTLA, Paul

jimsgtx, please do not lose sleep over predicted financial collapses. We just had a lulu in 2006-9, from which the world is still struggling to recover. Fortunately financial collapses of this size are unlikely to recur soon despite the usual scare mongering. Predicting disasters has kept many losers in the spotlight and employed ever since I can remember.

GLTA, Paul

At least one of my investments went up today - PPHM. Meanwhile Sunrise continues to enroll and treat patients all over the world. Maybe Peregrine will surprise us with some real information on how Sunrise is progressing. I know it is double blinded, but they must know some things about the trial.

GLTA, especially the Bavi patients,

Paul

I wonder if the after hours share price increase reflects somebody's belief that we will have good news tomorrow? I could accept that.

GLTA, Paul

Nice to see some new attention to PPHM. Don't know what is behind the recent share price move. However, every day Sunrise is enrolling and treating patients all over the world. Maybe some of them are feeling well enough to invest in PPHM. Just kidding; I suppose they have signed agreements not to buy PPHM or blab about the course of their treatment.

GLTA, Paul

These investigator sponsored trials seem very inefficient. They take forever to enroll, and then the investigators' reports take forever to reach publication.

Maybe Peregrine should stage their own Yervoy-Bavi melanoma study.

GLTA, Paul

Yes, why did JB keep those notes? For herself? Her employer?? Some third party???

So much about this simple mislabeling that just doesn't make sense to me. Was she trying to screw Peregrine? Assuming no bribery, why would she do that?

Maybe she was trying to screw her employer. Was she a disgruntled employee?

If nothing else, I hope this interminable law suit will eventually tell us why she did it.

GLTA, Paul

Fargo. I still have not heard any explanation for the pattern of mislabeling. Hard to see that it was meant to generate ineffective trial results - the high dose arm was not affected. The initial trial results jolted the SP over $4. The systematic mislabeling resulted in what looked like a triumph for Peregrine.

If the mislabeling was not designed to produce bad trial results, the only way to hurt Peregrine was if the mislabeling was detected. Was there any reason to expect that the mislabeling would be detected? If so, this meant that the mislabeller expected to be caught. Who commits sabotage with the expectation of being caught?

We are nowhere near understanding why this mislabeling took place in my view.

Just plain weird.

GLTA, Paul

I like to see Peregrine open new Sunrise sites. It just reinforces my sense that management is doing everything possible to ensure Bavi success at the earliest possible time.

GLTA, Paul

Once again the irrational IHUB PPHM posting volume indicator predicts another move up tomorrow.

GLTA, especially the Bavi patients around the world,

Paul

Meanwhile the pivotal Phase III Sunrise trial continues enrolling and treating patients. Must be 10 plus months since the initial 25 US sites opened. I hope we see amazing look-in data sooner than many expect.

GLTA, Paul

Good answer, wook. If you are correct, do you believe JB expected the sabotage would be detected? Or do you think JB thought the trial results would be so odd that the trial would be considered unreliable? I suppose the latter.

Either way, Bavi would be damaged and delayed.

GLTA, Paul

The Fargo Flap. If JB was attempting to sabotage the Phase II trial, why did the sabotaged trial results look so good? Was she the worst saboteur ever?

As some placebo patients got low dose bavi, this supposedly improved their outcomes. As the low dose bavi patients got some placebo doses, it supposedly degraded their outcomes. The high dose bavi patients weren't impacted.

So, the expected results would be the low dose bavi arm looks less effective vs. the placebo arm. The high dose bavi arm would look less effective vs the placebo and more effective vs the low dose bavi.

Other than confusing the trial results, this doesn't make much sense to me. If I was the saboteur, I'd randomize the dosing across all three arms.

How does this sabotage pattern make any sense?

GLTA, Paul

A lot is going on at Peregrine. Lawsuits, clinical trials, collaborations in the lab, potential partnerships, etc.

I have a sense that we will see some serious news in the next few weeks. Don't know what will catch fire. However, as the old expression says "Where there's smoke, there's fire."

We'll see.

GLTA, Paul

Darn, tried to buy at 1.32, but that wretched Fidelity didn't get me any.

GLTA, Paul

Good news, share price drops. I had to add. Could be a nice little profit when "the market" finally figures out that good news is better than bad news. LOL

GLTA, Paul

Sunrise protocols allow patients to continue to receive weekly bavi or placebo after their initial four month treatment. I hate to think of the patients who get the placebo wasting their remaining days on it.

Meanwhile Sunrise continues to enroll and treat patients. Hope to goodness the bavi arm patients are feeling better.

GLTA, Paul

You have to wonder what management in Tustin makes of md1225's efforts. Do they approve, disapprove, not care?

I certainly approve. It is tiresome to read all the negative stuff which ignores what is actually going on currently at Peregrine. md1225 may be a little too optimistic, but this balances the other point of view.

GLTA, Paul

Meanwhile, Sunrise has enrolled and treated patients for another month. Obviously we don't know when we will get a look-in, but the doctors and patients must be getting a good idea how things are going. Let's hope they are happy with the results.

GLTA, Paul

Verylong, a few years ago I decided to stop moaning and groaning every time the SP dips. Now on every SP dip without bad new I buy a few shares, and then cash them in with the next good news event.

I believe these opportunities will end with Sunrise data but that is a few months away. Might get to work this little money machine a few more times. If major good news comes out while I am holding what I consider trading shares, I'll just make more money.

In the unlikely, we hope, event that Sunrise is a bust, I will have offset my loss by the little profits made.

GLTA, Paul

md1225, thanks for writing the article and getting it out to the world. I made a little money on the SP uptick.

As to PPHM being undervalued, I don't know what that means. Other than we think Bavi is the real deal, and too many others don't know about it or feel comfortable betting on it.

In my view it all comes back to Sunrise. Irrefutable data will silence the critics, bring on serious BP interest and move the SP up to what we'd like.

More waiting to do. Meanwhile keep writing.

Thanks again,

Paul

duderaja, I like your plan. I have done it a few times. Nice to make a little money playing what look like short term peaks and valleys while waiting for bigger news. If the big news happens to come while I have trading shares in addition to my core of xx thousand shares, all the better.

GLTA, Paul

While I keep a core of PPHM share, I do like to buy the dips and sell into these little moves. Nice to make a little money while we wait for Sunrise, Yervoy-Bavi, Breast Cancer, Liver cancer, etc news.

GLTA,Paul

Based on the admittedly irrational IHUB Peregrine posting activity indicator, the share price will again rise tomorrow. That would be cool, wouldn't it?

GLTA, Paul

Today is just another example that "the market" knows nothing about Peregrine and Bavi. The miserable share price reflects Peregrine's obscurity; it doesn't say any thing about company management, history or prospects. I'm OK with that.

I just hope the extensive DD done by the optimists here has led us to the correct conclusion. That is, Peregrine has a great chance to help a lot of people and make us a lot of money.

GLTA, Paul

Dozens of collaborations. At the next CC I don't see why Peregrine could not provide detailed information. Exactly how many collaborations are ongoing? How many collaborators are universities? How many are US companies? How many are ex-US companies? How many involve vaccines? Are all directed at cancers? Which cancers? How soon will we see results? Etc, etc, etc. All the above could be provided without violating any agreements.

For that matter what confidentiality limits are there?

On Sunrise. Give us enrollment information. How many have completed initial treatment? Don't hide the data from us. The truth always comes out anyway.

On Avid. Give us a clearer understanding of the expansion. Why was it important to do it now?

We can handle the truth. If the company doesn't have anything to hide, as we use to say in the 60s Let It All Hang Out!

GLTA, Paul

biobs2012, I agree with the Peregrine critics on this point. Peregrine management does not work very hard at getting information to its shareholders.

Unfortunately, a very human reaction to this lack of news from the company is the assumption that management is withholding information to protect their own interests.

Prove them wrong Peregrine. Give us as much "color" as possible on all of the company's activities.

GLTA, Paul

Once again based on the volume of posts here on PPHM, I predict the share price will rise tomorrow.

You heard it here first.

GLTA, Paul

dia76ca, regarding these collaborations, Peregrine management must have negotiated terms permitting them to publicize whatever is learned. I hope we see some data from them soon.

GLTA, Paul

cheynew, it will be Groundhog's Day everyday until we get information on Sunrise or Yervoy-Bavi or who knows what. One thing is certain. Peregrine is entering a critical phase. If things break the way we optimists think they will, we will do very well. If they don't break our way in the next months, Peregrine will go on life support with a poor prognosis.

Too bad Peregrine management can't produce data to reassure their long-suffering shareholders. I like to think the data is still accumulating in the clinics and labs. My paranoia suggests there is data, but it's not positive. No way to know which.

Based on all the data we have seen to date, I like our odds. In fact I like them more than ever. In this critical period any gap in the news flow is scary.

GLTA, Paul

dia76ca, I agree with the we don't know who Peregrine is collaborating with. I wish Peregrine could find a way to flesh out these collaborations. In fact given the passage of time since the dozens announcement, I wish we could get some data from them.

GLTA, Paul

BCS Paladin, just for the record I don't think Peregrine is close to making a deal. I hope they are, but I like to think if a deal was coming soon the SP would be rising and/or some leaks would appear on this site.

GLTA, Paul