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<<When does/did Peregrine make the submission for BLA?>>
Sunstar, this is the critical question. The answer is in the sentence you quoted
"We believe this trial, when combined with bavituximab's supporting data to date, could be sufficient to support a future BLA submission."
Supporting data to date, not future data, that part is clear. Not sure about trial, is it just the approval of the p3 trial that would be enough or do we have to get some results first. Anybody???
<<This shareholder is prepared to pull the plug and walk with my profits>>
IMO the upside is much greater than downside. Late separation on KM curve for 2nd line NSCLC looks encouraging, it will be noticed. No telling at this point what will happen with the share price short term.
<<there are 9 patients in the 3mg/kg arm that are still alive at 29 months. >>
I think there are 9 patients alive in the 17 to 29 month interval, not at 29 months.
BLA vs NDA What are the differences?
We are seeing more and more specialty products coming to market via the Biologic License Application ( BLA) route, so what are the key differences? For a layman's definition look below:
"After clinical trials have shown that the new agent is safe and effective, there is reason to make the agent generally available to patients and physicians. The formal process in the U.S. by which this occurs is the approval by FDA of a marketing application (New Drug Application for cytotoxic/cytostatic agents or a Biologic License Application for biological agents) submitted by a private firm. The applicant seeks approval from FDA for one or more specific indication(s). Review and approval of an NDA or BLA are based on the demonstration of safety and efficacy assessed from detailed reports of the clinical trials; particularly randomized controlled studies. The contribution of a new agent in the treatment of a disease is demonstrated unambiguously if the agent is the only variable between the treatments."
http://specialtyrxfacts.com/?p=493
<<the vertical axis represents the estimated probability of survival not the actual % of patients still alive>>
You are correct. However, according to the KM curve, in Bavi arm anyone who made it to the 17th month should also make it to the 29th month. What we don't know is how many are there between 17 and 29 months, and if I got this right, an event between 17 and 29 months will change the shape of KM curve.
<<Where did you come up with 12% and 30% alive? Based on the poster it shows 54% of 3mg/kg arm deceased and 75% of control.>>
From the KM graph. Look at the left on y axis - the control is at about .12 or .13, Bavi is at about .30.
http://investorshub.advfn.com/uimage/uploads/2013/6/2/syfoeASCO12_2L_NSCLC_Poster8095.jpg
OK, so looking at the KM is it correct to say that in the control group nobody has survived more than 23 months with 12% still alive and in Bavi group it is up to 29 months with about 30% still alive. Also in Bavi arm there are no deaths past 17 months - does that suggest remission?
The control KM curve stops at 23 months. What is the reason for that? The Bavi KM goes to 29 months.
<<Am I correct in saying that as long as the end point has not been met till this point that the HR and P values can still improve?>>
That is correct, HR and p should improve with time. MOS will not change.
It closed at 1.645. The 1.71 price was on 1300 shares in AH trading which doesn't mean much. Price-wise this week was a disappointment.
<<Now FDA oncology head is holding back the "cure" for cancer?>>
Not now, but he was. He held back Provenge immunotherapy for prostate cancer and should have been excused from the committee because he had clear conflict of interest. Go ask on DNDN IV board, they'll tell you more. This is all public record, I and many others know what he did.
<<we might get to 2$ AH :)>>
We might, but not today. AH trading ends at 8PM.
Pazdur is a crook. He is responsible for the 2 year delay in Dendreon's Provenge imunotherapy because he had a conflict of interest. Now, suddenly, he is all for giving a fast track for the therapies we was against just a few years ago. He should be kicked out of FDA.
<<I do NOT believe the Front Line NSCLC has Evented>>
I like to believe you are right, it would be great. However we need more transparency, it is not a blinded trial and they could provide some feedback to lift the share price. There is no reason for secrecy. I just don't like the management. IR at some other companies are much friendlier and tell more when one calls.
What happens to the call options if poison pill is triggered?
Do we have the time table for the ASCO presentations?
We were all expecting a runup into ASCO, yet the share price is lower than three days ago. Premarket is dead, no PPHM trades. Ask 1.68, bid 1.63. It could be another low volume day. Futures are down, the market will open in red.
That was no serious bear raid. Somebody sold about 80K, maybe our friend H4B shorting more.
<<its gonna be sell on the news anyway>>
It could be but the risk/reward is not in your favor. You may gain pennies if it goes your way or potentially lose a lot more. Good luck to you
C'mon, that Keryx takeover rumor from Sierra is dated March 1. Nothing happened, just like nothing will happen with PPHM rumor from Sierra.
<<She (sierra)got it correct with srpt months ago.>>
Sure, one makes a bunch of wild predictions and once in a while it will be right. What you really have to look for is the overall reliability of her predictions and I don't think it is greater than 5%.
You are right about two levels of interpretation when it comes to combining control and 1mg Bavi. Market and especially hedgies should also be aware of that, yet the stock price is way down. Too much optimism and exuberance on this board. Obviously the world outside of the ihub is a lot less optimistic about Bavi and PPHM. Should be a rally into ASCO - we are down 3.5%.
<< PFE issues $4 billion in a new debt facility expected to close June 3rd. Very peculiar timing. I'd take $30/share>>
4 billion would be $29.2 per share. So, you are close with your estimate but I don't see it happening, not yet anyway.
Do you have any June and July calls? I am short a lot of $2 June call contracts.
OT: Did anybody look at the FNMA today? Mad house.
Counting dilution 5.50 is equivalent to about 3.70 today. Yes, share price moved to 5.50 (3.70 today) without a partner but at that time the MOS for the Bavi arm was at 100% and was also stat sig. Phase III, AA, partner etc was all expected to happen quickly. Today we have 60% MOS and p3 only. Big difference. First line is the key now and it would have to be at least 80% better than SOC to lift the stock to $3+.
Could it be that Garnick is leaving and they have to replace him?
<< and working knowledge of non-US regulatory systems preferred >>
Non US regulatory systems?? Why??
<<ASCO run-up is a sure thing.>>
What makes you think so? We haven't seen anything spectacular in abstracts.
This is interesting. Does it mean Bavi has been manufactured exclusively by Lonza or some Bavi is also made at Avid? Per the quote above Bavi for commercial purposes can't be made by an outside contract manufacturer. The contract is between Lonza and PPHM, would Avid be an outside contract manufacturer in this case?
<<As soon as tomorrow i don't see it under 2 usd>>
What particular event or announcement do you expect tomorrow to boost the share price by 30 cents?
HER2-negative metastatic breast cancer results
complete response (1),
partial response (6),
stable disease (1),
progressive disease (2)
too early to evaluate (4).
Complete response - The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Also called complete remission.
Doctors use the term partial response to describe a tumor that has decreased in size by at least 30%; progressive disease is used to describe a tumor that has increased in size by at least 20%, or spread since the beginning of treatment.
Cancer doctors use the term stable disease to describe a tumor that is neither growing nor shrinking. Stable disease also means that no new tumors have developed, and that the cancer has not spread to any new regions of the body (the cancer is not getting better or worse).
How is this in comparison with SOC? Anybody?
Yes, very good close, I expected more than 8 cents on such high volume. Who the hell sold almost 5 million shares going into ACSO and why? H4B you didn't short all those 5 millions, did you?
<<50 $2.50 June calls for a nickel? Easy money for your trading shares. >>
No, not now. It was good money a few days back with PPHM trading at $2. I sold 1000 calls at $2 strike, bought more shares with proceeds, we shall see how it turns out. How many of those calls did you buy?
You are right, management's lack of transparency is largely responsible for the low share price. Retail stockholders on any board always cry foul and conspiracy when the stock drops, PPHM is no exception.
After the p3 announcement a bunch of smaller operators jumped on the opportunity to short the stock. That was to be expected, there is usually a pullback after a surge. I did the similar thing - I sold a bunch of June covered calls on my trading shares for a nice premium while the PPS was around $2.
ASCO is next month, we will find out more about some of these trials, and the first line data will have to be released within a couple of months. If all good we will get a nice rally.
<< we are actually on better standing ground than where we were in September, so should at least be back to $5.>>
Wishful thinking. In September we had 100% increase in survival, 1mg and 3mg combined as a one group was statistically significant. With result like that partnership, p3 and accelerated approval were all in the bag till the labeling mixup surfaced.
Now we have 6 months delay, 60% survival benefit, no stat sig, p3 approved with no AA. How is this better than back in September?
To get the stock back to where it was in September we need great numbers from first line, and when I say great I mean almost 100% benefit over SOC. We also need a BP partner.
<<Yesterday was the day to sell>>
Did you? Hindsight is always 20/20.
Company requests a trading halt before announcing news. It was halted per Peregrine request.
DewDiligence << Almost everyone with no financial interest in the respective companies would say that there are more promising drugs in clinical development for NSCLC. >>
Would you give us a few examples and links please. Words are cheap.
<<Peregrine should be worth more now than it was then.>>
Not true, before the labeling fiasco MOS was double, almost too god to be true and it was also stat sig when combining 3mg and 1 mg Bavi. Now it is 60%. Pancreatic cancer didn't look all that great either. First line results could lift the stock considerably.
Shorting PPHM at this level could be a big mistake. Partnership announcement can come at any time now and the share price will go thru the roof. Days of $1.50 are over, downside from here is in pennies at the most.
We could get a bear raid which would actually be a buying opportunity. So, I am putting in a ladder to buy more shares cheap if they attempt a raid.