Learning Curve, I think this is closer to the truth too. Good post. Three years of legal fees and settle with no admission of guilt by any party. With no breakdown of SG&A shareholders need to know if more cash is being spent on legal or Sunrise enrollment? Highly likely that's how it goes down, in our opinion.
What's this about, Antwan?
"After all the hype about Swartz' buying through the years, and now to find out disclosure wasn't even required?"
-Strange CSM defense makes no mention of 25% mix up within placebo and 1mg. Could that part of it have been Avid's fault?
-Judge says "I don't see this case going that long given what I know of the claims. It's a straight forward breach of-contract claim; so I don't see why it should take 15 court days to try..." So where does that leave them on constructive fraud?
-it's almost as though JB has no understanding of Perceptve's function in all this. Impossible for Perceptive to perform without correct assignment codes.
-From reading one gets the feeling Shan&Co. thought they knew treatment group assignments, which is in violation of a blinded study, of course.
-Feels like Perceptive should've managed CSM and not Peregrine??
Just some quick notes on JB's declaration:
-No mention of Masten anywhere.
-Why the mix and not just a clean swap?
-Why would Peregrine have to investigate and examine vials over months if JB had the correct final correct group assignments?
-Label type/brand still unresolved. Could be as simple as CSM ran short and used what was around. Might also explain Finkens desire for an on-premises machine??
"In September 2012, Peregrine received pharmakinetic ("pk") results from the testing laboratory which evaluated blood supplies from a subset of 18 patients who participated in the pk "substudy." Those 18 patients were evaluated for potential drug-drug interaction between bavituximab and docetaxel. With that information, and a drug coding memo from CSM, there were indications that the "A" and "B" treatment assignments may have been switched, but CSM provided no explanation or elaboration"
Antwan, yes Avid could've of messed up the delivery, we suppose. It'd mean they somehow screwed around with the placebo meant to be infused with Docetaxol in the control arm. The placebo was manufactured where exactly we do not know- Avid or outside supplier? And did the Docetaxol come from Avid too? So many questions still.
That said, were not hearing CSM mentioning this as an issue, right?
Yes, looks like we're talking about the same thing. Don't know what to make of it. Seems like Finken is reinventing the wheel here. Talking about saving money on labels is like buying regular unleaded for your Ferarri. This particular label operation should be like printing scratch offs, we would think, accounting for every single label, destroying overruns, and securing inventory in a safe or cage. Having an "In-house" machine that can just make labels as needed seems odd.
You're referring to this?
SYSTEM AND METHOD FOR LABELING TRIAL STUDY MATERIALS
Application number: 20140237950
Abstract: The present disclosure relates to methods and systems for labeling trial study materials. The method, in some embodiments comprises the steps of providing bulk supplies to one or more study supply depots, receiving one or more requests for at least one study test kit at the one or more study supply depots, packaging the bulk supplies into one or more study test kit components, printing at least two different study supply label types on a single label sheet, affixing the at least two different study supply label types to the study test kit components, packaging the study test kit components into at least one study test kit; and shipping the at least one study test kit to a trial site.
Filed: February 22, 2013
Issued: August 28, 2014
Assignee: Clinical Supplies Management, Inc.
Inventor: Gerald Finken
Thanks. The labels...Yes very strange. The switch...Can only think it'd be for compassionate use. What do you think?
Great team...Only if you guys demand board change.
So who did it and why? If you're the SEC it'd be pretty simple to track the trades, right?
See new post '2 of 2' on separate thread.
So let's say he did then who tipped him off? when do you think King&Co. really knew?
A. Culprit/s wanted to shut/slow down Bavi with as little potential harm to patients as possible.
B. Culprit wanted to sell Bavi on the black market.
C. Culprit wanted Bavi for personal use (both assume not a one for one A&B switch).
D. Culprit wanted enough biologic to test/manufacture generic version.
E. Peregrine executive/s did indeed consent.
1. Did consent by ignorance/accident
2. Did consent intentionally to cause damage/ trading opportunity
3. Did consent out of compassion.
F. CSM was deliberately set up.
1. Set up as fall guy/scapegoat.
CSM made scapegoat for a Peregrine rigged/flawed Pll that was exposed by Feuerstein and others.
2. Set up by disgruntled CSM employee.
3. Set up to be sued for legal/award fees following previous successful award in similar suit.
G. Culprit wanted to pump and dump the share price for financial gain
1. Culprit is a CSM insider
2. Culprit is a Peregrine insider
3. Culprit is a third party.
H. Culprit had hoped to pressure Peregrine into selling out of desperation.
1. Culprit is BP who was apparently in deep talks at the time
2. Culprit is other Big Pharma bidder
I. Culprit had hoped to eliminate competition
J. CSM Project Manager is simply unstable.
K. It's all just an innocent error that has snowballed out of control.
We are unable to post Part2. Stay tuned.
Sorry a little scattered but twenty plus years experience. Hope they're of some use.
"In court documents, CSM denied any wrongdoing, saying, “Peregrine consented to and approved the alleged acts for which it now complains.”
"The question of why CSM would swap the A and B groups is not answered in the complaint. But Peregrine argues that a CSM project manager “secretly decided for herself to deviate” from the agreed-upon method of conducting the study. She then concealed her decision, Peregrine alleges."
By: Adrian Glass-Moore, Forum News Service
Here are all the hypothetical we could Construct along with notes
-Who caught the error is critical. Must confirm.
-Peregrine had minimum six months to find the error but didn't test for presence of Bavi in blood, which seems extremely odd and not in keeping.
-Confidential witnesses implied Peregrine was reckless
-Why no tampering with the larger 3mg dose arm?
-Arm switch likely could not have been successful had Bavi shown its own set of side effects.
-Alleged Label type/brand switch is critical. Must confirm.
-Note the Black Monday pr coincided with retail finally able to margin
-Assume SEC investigated possible pump and dump money trail, if any. Must get confirmation.
-If pump and dump scheme we must confirm who caught the mix up and/or who was tipped off about the mix up. Who did the tipping?
Part1 of 2
Tithe it right! Nobody really knows whether Avid profits or not. Just look at research/SGA and 180 employees with matching 401ks. The figure is staggering for a $250 million market cap company. Looks more like Intercept who have nice pipelines and billions in market cap. AND YET NOT ONE ANALYST IN ALL THESE YEARS HAS EVER SUGGESTED CUTTING HEADCOUNT.
We've posted our position in the past. It's long, sagging, and unrecognizable. Unless one was maybe hedging and had some real good inside knowledge and control, you'd have to be absolutely mad to short here at this near low share price.
Ha! No, just that the usual posters were behaving somewhat like parishioners.
But there you have it! Always a good read anyway.
In th past we've posted what Fastrack really means according the an ex FDA official- Means nothing. And as for look-ins, so what!