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Can't see anything
Paul, I guess we both agree that this is all pure speculation... Simulations and models just try to follow reality but obviously they are not reality. Anyway my exercise just shows that the same way some people are positive that 1st lookin has happened some others (also from pure speculation) "think" reasonably otherwise.
Best is knowing not "thinking"... But
On the other hand I am not so sure about what you mentioned:
" when each site came on line, they already had at least one patient."
Paul as I said in my post, I took the enrollment model from Golfho, because it made sense. I assume he took the starting enrollment dates from Hospitals from factual data and from then onwards he applied the criteria of 1 patient after 4 months the Hospital started SUNRISE and another patient 4 months after the first one.
The fact is that this scenario seems to fit with what PPHM is saying is happening.
The chart below shows the "hockey stick" type of enrolment Joe Shan talked about. Also the "events" curve corresponde to "good" perfomance from both BAVI & Placebo arms.
The Excel itself was / is fantastic (I mean Golfho's). Great work... However different approaches and different starting hypothesis may lead to different conclusions.
I dont claim to be right, I just say that if the hypothesis I base my approach are reasonably accurate then 1st lookin will not take place during the summer.
I believe that 1st lookin has NOT taken place yet… I have done another simulation that estimates possible dates for the lookins and they seem to be quite later than many here have expected. Actually 1st lookin will not happen until October 2015 (if both Arms BAVI and Placebo perform poorly) and Decer 2015 if BAVI and Placebo Arm perform really well (according to past records)
My approach goes as follows… I have used the excellent spreadsheet that Golfho prepared and in particular one of his 4 Scenarios that assumes that a patient is enrolled 4 months after site opening and 4 months between enrollments
ENROLLMENT
These results gave 595 patients enrolled by November 2015 and that fits very well with the comments from PPHM: “Enrollment is going according to plan (end of 2015)”
So I took this numbers for this new approach.
Also any patient should belong to any of 8 groups according to the time they event : 3 , 5 , 7, 9, 11, 13, 15 months or they are survivors. Patients will be grouped by the months they are still alive after enrollment.
Let’s also consider 9 Cases (Scenarios) depending how good/bad the Bavi & Placebo Arm work. The percentage of “eventings” for each group tries to have a Median OS of 7,9 or 11 for the Placebo Arm and a MOS of 10,11 or 13 for the BAVI Arm
EVENTING GROUPS AT DIFFERENT SCENARIOS & PERCENTAGES OF OCURRENCE
So again any patient should belong to any of these 8 groups (according to the time they event : 3, 5, 7 months etc.) and Patients will only start “eventing” after at least 3 months after they have been enrolled. The calculations of “events” will be done according to the forementioned percentages. Do not mistake Enrollment Groups with Eventing Groups.
Calculations were made and These are the results per Case of number of Patients who had “evented” at the beginning of each month in 2015
RESULTS PER CASE (SCENARIO)
So not until next October 2015 we find 169 events… and that corresponds to a bad performance of both the Bavi and the Placebo Arms.
For a GOOD Bavi (and Placebo Arm) performance (Case 1) we would have to wait until December 2015 for 1st lookin
If you have read this far you deserve some more detailed explanation on how the calculations were made.
Let’s find out how many events took place beginning of this month (July 2015) and for Case 1. We should start by looking from 3 months behind (April 2015) backwards till 15 months behind (April 2014) to come to the following distribution of patients according to the time of enrollment:
These numbers can be checked, for instance in April 2015 (3 months before July) the total number of enrollments is 308 (see at the top), etc.
So we start with the group that has been enrolled more than 15 months: 1 person.
Survivors: 1 x 0.04 = 0.04 (not considered) Group of Eventing in 15 months = 1 x 0.05 = 0.05 (not considered)
“Total to exclude” = 0 + 0 = 0
We follow to the next Enrolled Group: 13 months =< enrolled <15 months. Number 9 – “Total to exclude” = 9
Group of Eventing in 13 months = 9 x 0.18 = 1.62 (we consider 1)
“Total to exclude” from this group and prior = 0 + 1 = 1
We follow to the next Enrolled Group: 11 months =<enrolled<13 months. Number 14 – “Total to exclude”=14–1=13
Group of Eventing in 11 months = 14 x 0.23 = 3.22 (we consider 3)
“Total to exclude” from this group and prior = 0 + 1 + 3= 4
We follow to the next Enrolled Group: 9months =<enrolled<11months. Number 77 – “Total to exclude”=77–4=73
Group of Eventing in 9 months = 73 x 0.23 = 16.7 (we consider 16)
“Total to exclude” from this group and prior = 0 + 1 + 3 +16 = 20
And so on and so forth… until we come to the number of 70 events by July 1st
CONCLUSIONS
If the enrollment model is relatively accurate (which I think it is) we can conclude from the results of this approach that even with a bad performance for the Bavi or Placebo trials the 1st lookin does not seem to happen before October 2015. From October 2015 onwards seem to be reasonable time frames for the 1st lookin to happen. However 1st lookin and 2nd lookin are very close to each other.
I will be happy to listen to any arguments against this approach. Unfortunately I have had no one checking the hypothesis I have taken nor my calculations, so I admit errors are possible… Yet the results say we will still have to wait a while until the lookins take place. No problem for me.
If anyone is interested in this spreadshit and wants to play around with different strategies please send me an email (my email is traderon74@yahoo.es). The spreadshit is based on an impeccable Excel that Golfho made.
thanks so much
it works
I would like to post a MS Word paragraph that includes some images...
I paste it but the images do not stay
I tried "image" and paste in there and does not work either.
anyone can help?
thanks in advance
Correct Bio, this is the transcription....
(Joe Shan)<<To protect the integrity of this double-blind trial, an independent data monitoring committee has been established to evaluate safety data on an ongoing basis and make recommendations to Peregrine as to when the trial should be unblinded. As the interim analyses are triggered after pre-specified numbers of trial events are reached, in this case, deaths, we cannot, at this point, guide to when these might be reached, but we will be sure to provide updates as soon as we can.
Then why did Joe Shan use the future tense? Why missinforming?
<<The first interim analysis, which will be conducted when 33% of the targeted overall survival events are reached, is for futility and the second interim analysis for futility or predictive success, will be conducted at 50% of events>>
Great CC though
Everything went as expected... you dont go to a lion, open its mouth, put your arm inside... and expect that nothing is going to happen LOL
" Bavi is a placebo" , "will never make it to PIII" "PIII will never recruit enough patients" "PPHM cherry picked all the data" etc... speaks volumes... Enough to have a clear picture of what is goin on.
At least for me.
Chris I respect you a great deal and I love your articles (thank you for them). Yet I do not understand your special interest in someone's opinion... unless that someone is a real pro in the field which may not be the case for most of us here on this message board...
My point being: Is it worthwhile asking for someone's opinion when that opinion may go in whichever direction including against yours... Not pointing my finger to anyone in particular, but many people here (of course not all) are driven by their own agendas or just by their own moods...
What will really make a difference are facts: either as a partnership or as trial results. Period.
AIMHO
by the way, what degree of expertice would show a shameless and not taken back statement such as "Bavi is a placebo"
Agree... I also liked BM's presentation... In regard to the only 2 questions I am not sure that was not intended indeed by the Co.
It is very convenient for them not to have any uncomfortable question or complaint from unexpected shareholders
Bio, maybe he is not liying. Maybe BMY is not openly involved in that collaboration but that does not mean they are not interested in the results (which obviously they are). Maybe they feel comfortable enoughh to have MSK doing it for them.
For whatever reason they want to keep a distace. That is fine with me.
Scruffy, I see a big difference with RMBS... IDCC climbs and climbs...
Legal System may also be against the lsmall fich but pps does not seem to care
LOL... that was all the negative he could find from ASCO?
Of course positive stuff PPHM doesnt come in his book
I dont see why you exclude anyone (and that includes DD) in your observation about posters with "unrealistic expectations" within this board... Or is it just because his expectations were always on the negative or super negative side(the placebo that will never come to PIII)
Are you sure about it? That would be true in another pps phase... First there willl be news about PIII or partnership or yervoy etc... That should move us away from the 1s... when we pass the $5 mark THEN institutions may start playing
BTW I love ur "name"... It is an abosulte truth
Wow CP, I love wishful thinking... LOL but 50 x 10 = $500 is such a pie in the sky that I rather stick my feet to the ground!
Setting expectations too high leads to dissapointment and nobody likes that.
Let me guess:
12/31/15 : $ 1.9
6/30/16 : $ 2.9
12/31/16 : $ 5.0
Any other "positive" news? Nevertheless I would appreciate if you could provide with some reasonings to your STATEMENTS
I also give a chance for a bit more of dilution... and possibly they will be getting richer... but I believe I will make a nice return on this investment
the "botched trial" staff I think is BS, wrong wording
and "No volume"... obviously now til we get some news (one way or the other) volume will stay like that
Bavi is working man! I know it
That is certainly great news... IDCC is really involved in 5G
But I suppose there is also an Insurance Company that should take care of all the damages... Now, the thing is how much is the maximum committed
I see the announcement, however no media here has said a word about the launch. Promo is null, or nada as you wish
I see in their website (Recordati -Spain) that they offer Virirec (Vitaros)
http://casenrecordati.com/producto/virirec/
Too bad they have not approached any media ... yet
Timing is quite good though, considering that in summer Spain's population doubles because of tourism
I wonder the price... I 'll check
DD, would you admit that your expertise in things PPHM is not that accurate?
Just a little reminder of your previous statements:
(in chronological order)
- PPHM cherrypicked all the data
- Bavi is a placebo (I admit you have the copyright on this one)
- Will not pass PhaseII (NSCLC)
- Will not get enough patients in PIII (to be seen)
thanks in advance for your kind reply
respectfully
J
You may be right abot the downtrend... but is that a proof that it will never come up? On the contrary, with the tremendous potential PPHM pipeline has... a reversal (sorry huge reversal) will take place!
IMO
As always I dont agree with you... no proven science? Let me see:
- Preclinicals do not agree with you at all
- In humans, NSCL PII had "decent" final data... and if "sabotage" (= intentional dose switching) data were extraordinary
- breast cancer data were very good (wait awhile longer you may get very sad)
- liver data look promising considering the state of the patients and its limited number
So, that is why I keep invested and have an interest in the stock even though my posts are very few... at least compared to others
You missed another point:
PPHM cherry picked all data
Of course there is no partner on board... That is obvious
But that is NOT what you said in your post... If you say nothing "in the works" I understand you believe they are not in discussions with anyone...
And I do not think that is fair to state that... because WE dont know (I dont know and I am afraid that the "we" also includes you)
Howcome are you so sure there is no partner in the works? I mean do you have insider knowledge... You could have said "I wish there is no ..."
But I guess I miss "IMO"
Nice Wook, thx for the info
Carboat, how many times do you need to be told the story behind those "failed" trials ... that I do not consider to have failed or in other words that I do not consider that Bavi will not be able to help those patients in normal circumstances ... and not in a very advanced cancer stage as the patients were in those trials... or the own idisincracy of those cancers.
But, hey! that would not worthy... fun is spotting any possible flaw in Bavi (even if it is imaginary) and post it as many times as possible
Will that make it true? I dont think so
That's because:
1. "Bavis is a placebo" ?
2. "Bavi will not pass PII" ?
3. Or because PPHM will never recruit that many patients for PIII?
Of course, your opinion is highly considered on this board, since you and your pal AF are supposed to be big experts on BIO Cos.
I for one enjoy the tweets you share with him about PPHM and its diehard longs.
Why? Is HALO also dealing with placebos?
Things look good around RMBS... Let's hope that the ASM is as good as last year's
You are right r_m they do say it is on track... because they do have an idea of how enrolment is going... At least they have plenty of avenues to find out, at least more or less, the number of patients on the trial
IMO
Are you sure there is no way for PPHM to know how enrollment is going? Why? The fact that the trial is blinded should not mean that they wouldnt know how much Bavi has been distributed, etc. Or if as they say they are in contact with the Hospitals why the number of enrolled patients should be a secret?
IMO
Question: How many have invested in PPHM because of the CSM trial?
At the end of the day this trial will make no much difference in Peregrine's future and I see no point in so much arguing for the sake of arguing
At least I do not trust the Court System enough, and if it were a sabotage big pockets will make it moot and if it was PPHM's negligence even the dumbiest learn from their mistakes.
Let's focus on what really matters: PIII and what new combos can bring.
Unfortunately patience is needed and no real need of the money you have invested in PPHM
I rather be an optimist... I see no reason not to be so
Very interesting. Thanks for the link EOM
I find that post insulting or at least disrespectful with some posters I DO respect here on this board... I know no names were listed but no need to be a genius to grasp his intention... If hunting season is open please let us ALL know
I bet the author of the article visits (and writes on?) this board.
Why that? He/she superficially mentioned a few points going on with the Co, just to prove he is familiar with it but explicitely underlining his negative conclusion: PPHM is dead meat for 2015...
Who would take the pain to write such a meaningless story unless you want to leave a clear message: do NOT invest in PPHM
If for whatever reason you are on a mission, i.e. discredit a particular company.... you stick around the web sites or blogs where you can exercise your task and iHub is THE place to do so.
Interesting also he didn't sign with his real name. Shame on SA they allow such