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Did Swartz leave Roswell?
http://roswellcapital.com/team/
Maybe it's just me wondering but if Thorpe really said that to you two did he not just violate the company's edict of not releasing any information during the "Internal review/ Investigation? I'd think that was pretty serious.
Also wanted to point out to those of you that don't believe tampering with a trial is possible. Then why would they write a book about and have a training program on:
'Detection and Prevention of Clinical Research Fraud and Misconduct A Norton Method Skill-Based Training Program'
http://www.squidoo.com/norton-scientific-scam-detection-and-prevention-of-clinical-research-fraud-and-misconduct-a-norton-m
My one allowed post.
And it doesn't occur to anyone here that "management" may have possibly faked these "interim" "Gold standard study" results for their own monetary benefit? I have a question: What would you need to see and what's your time fame for discovery (before your patience runs out)? Anybody?
Some of you are very telling with your constant assertions about 3rd party law suit wins, survivors actually existing, waiting for MOS, and an investigation in progress with results due any time now.
TO BE CLEAR, none of this bears any resemblance to reality.
You're answer, if one ever comes, will most certainly be NO, since the trial groups are far too small in size. But I'm sure with Garnick's inside track record they'll work a good story.
"...be able to at the end of the day see what we can [take away] from this study because it is still an important study"
Note: Garnish was replaced by "take away"
Or maybe he meant "embellish".
Does this seem at all promising to you? Really!
Are cancer patients' hopes for chemo too high?
"These are not trivial issues. Chemotherapy near the end of life is still common, does not improve survival, and is one preventable reason why 25 percent of all Medicare funds are spent in the last year of life,"
http://www.reuters.com/article/2012/10/24/us-cancer-patients-idUSBRE89N1M220121024
Horse, I wager they'll be thrown away.
-"Bring back the data and completely reevaluate the study"
-"You really can't rush doing a complete and thorough job on a very complex project like this"
-"...be able to at the end of the day see what we can garnish from this study because it is still is an important study"
-"Patients that were enrolled in the study certainly deserve that we get the most out of this study we possibly can"
-"Give an update on where we want to take the program from that standpoint"
-"But again, multiple data points coming (from other trials) besides the completion of this particular investigation"
-"1000's of vials of drugs, thousands of patient sample, many different vendors, reviewing of operations of multiple venders"
Steve King from the Annual Meeting
GARNISH?
Smart post, Eyebuy. Of course the ATM is in full swing again since they did not come out and say it wasn't. The only question is, at this particular point, are they in violation when it's used and were they in violation on the $15mm candy store run??
Well, KT, that's a nice neat package you wrapped up for us. Nevertheless, I still think there are a lot of issues surrounding the timing of that particular ATM with regards to material information disclosure and whether the instrument itself was allowed to be used. Why else would scores of law firms chase Peregrine if they didn't think they could get a piece of that $15mm? It's not like they have much else to grab.
And for the record, I monitor both boards and it was FiduciaryDoozy who brought up the idea that the bank loan was returned pronto to raise money via the ATM.
That $15,000,000 ATM was executed when?
(pp) Clinical Studies. The clinical, pre-clinical and other studies and tests conducted by the Company were, and, if still pending, are being, and, to the knowledge of the Company, the clinical, preclinical and other studies and tests conducted on behalf of the Company by third parties were, and if still being conducted on behalf of the Company, are being, conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, the U.S. Food and Drug Administration’s (the “FDA”) Good Laboratory Practices and Good Clinical Practices as well as all other applicable rules, regulations, or requirements of the FDA or any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). Except as set forth in or contemplated by the Registration Statement and Prospectus, the Company has not received any written notices or other written correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA requiring the Company to terminate or suspend any ongoing clinical or pre-clinical studies or tests.
Read more: http://www.faqs.org/sec-filings/110613/CURIS-INC_8-K/dex11.htm#b#ixzz2A9jpgoMJ
Guess no more ATM's until lawsuits are over??
(q) No Litigation. Except as set forth in the Registration Statement or the Prospectus, there are no legal, governmental or regulatory actions, suits or proceedings pending, nor, to the Company’s knowledge, any legal, governmental or regulatory investigations, to which the Company is a party or to which any property of the Company is the subject that, individually or in the aggregate, if determined adversely to the Company, would reasonably be expected to have a Material Adverse Effect or materially and adversely affect the ability of the Company to perform its obligations under this Agreement (collectively, the “Actions”); to the Company’s knowledge, no such Actions are threatened or contemplated by any governmental or regulatory authority or threatened by others that, individually or in the aggregate, if determined adversely to the Company, would reasonably be expected to have a Material Adverse Effect; and (i) there are no current or pending legal, governmental or regulatory, actions, suits, proceedings or, to the Company’s knowledge, investigations that are required under the Securities Act to be described in the Prospectus that are not described in the Prospectus; and (ii) there are no contracts or other documents that are required under the Securities Act to be filed as exhibits to the Registration Statement that are not so filed.
Read more: http://www.faqs.org/sec-filings/110613/CURIS-INC_8-K/dex11.htm#b#ixzz2A9iBzGGP
They sure did get that loan back in the nick of time
(s) No Material Defaults. The Company has not defaulted on any installment on indebtedness for borrowed money or on any rental or one or more long-term leases, which defaults, individually or in the aggregate, would reasonably be expected to have a Material Adverse Effect. The Company has not filed a report pursuant to Section 13(a) or 15(d) of the Exchange Act since the filing of its last Annual Report on Form 10-K, indicating that it (i) has failed to pay any dividend or sinking fund installment on preferred stock or (ii) has defaulted on any installment on indebtedness for borrowed money or on any rental or one or more long-term leases.
Read more: http://www.faqs.org/sec-filings/110613/CURIS-INC_8-K/dex11.htm#b#ixzz2A9hwE9bU
Was that last ATM sale legal?
i) No Material Adverse Change. Subsequent to the respective dates as of which information is given in the Registration Statement and the Prospectus, there has not
7
been (i) any Material Adverse Effect, (ii) other than this Agreement, any transaction which is material to the Company, (iii) any obligation or liability, direct or contingent (including any off-balance sheet obligations), incurred by the Company which is material to the Company, (iv) any material change in the capital stock (other than (a) as a result of the sale of Placement Shares, (b) as described in a proxy statement filed on Schedule 14A or a Registration Statement on Form S-4 and otherwise publicly announced, or (c) changes in the number of outstanding shares of Common Stock of the Company due to the issuance of shares upon the exercise or conversion of securities exercisable for, or convertible into, shares of Common Stock outstanding on the date hereof, or the vesting of restricted stock units outstanding on the date hereof) or outstanding long-term indebtedness of the Company, (v) any dividend or distribution of any kind declared, paid or made on the capital stock of the Company, other than in each case above (A) in the ordinary course of business, (B) as otherwise disclosed in the Registration Statement or Prospectus (including any document deemed incorporated by reference therein) or (C) where such matter, item, change, or development would not make the statements in the Registration Statement or the Prospectus contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading;
Read more: http://www.faqs.org/sec-filings/110613/CURIS-INC_8-K/dex11.htm#b#ixzz2A9hOqI5E
Minimal management involvement. At-the-market
offerings require no “roadshows” and involve
only limited prospectus preparation and delivery
requirements.
Regulation M
Generally, most at-the-market offerings are
conducted for issuers that meet the ADTV test. In the
case of securities that do not meet this exception, one
must analyze each at-the-market offering based on its
magnitude and whether it involves special selling
efforts that would make it subject to Rules 101 and 102.
Note that Rule 104 of Regulation M prohibits
stabilization activities in connection with at-the-market
offerings. In addition, most at-the-market offerings are
“best efforts” offerings, which are exempt from the
short sale restrictions of Rule 105 of Regulation M.
http://www.mofo.com/files/Uploads/Images/FAQAtTheMarketOfferings.pdf
Share dilution scams
A share dilution scam happens when a company, typically traded in unregulated markets such as the OTC Bulletin Board and the Pink Sheets, repeatedly issues a massive amount of shares into the market (using follow-on offerings) for no particular reason, considerably devaluing share prices until they become almost worthless, causing huge losses to shareholders. Then, after share prices are at or near the minimum price a stock can trade and the share float has increased to an unsustainable level, those fraudulent companies tend to reverse split and continue repeating the same scheme.
http://en.wikipedia.org/wiki/Stock_dilution
I think just about everyone here knows now that 3rd party error was just a quick fabrication to get the heat off them. Again, they are conducting an "Internal review" and didn't even mention "3rd Party" in the last PR.
It's a sickness of some type, I'm sure of it.
"I voted for the options as a bonus for doing what they had to"
And with more and more of its activities moving overseas, the industry’s behavior will become more impenetrable, and more dangerous, than ever.
Many U.S. medical investigators who manage drug trials abroad say they prefer to work overseas, where regulations are lax and “conflict of interest” is a synonym for “business as usual.”
Wow! you STILL don't get it. There is only an "Internal review" (I know...I know, "management uses "Investigation" from time to time but that's only to defuse shareholders anger. It should be obvious by now that "management" always takes the road most dark, that's their way. You'll never get to the bottom of that "Gold standard" study...You know, the one that "management" says they "owe it to the trial participants to get to the bottom of". LOL! They don't owe it to shareholders. Not even an apology to shareholders for the screw up or misconduct. Terrible.
Endoc, Not only not a new problem but so old that it could be called the oldest trick in the book. What better way to pick up millions and blame it on somebody else...And with FDA cover to boot! You don't think Garnick, King&Co. knew about this potential issue? Since it was covered in Vanity Fair I'd sure hope they did.
But Shan did say results were evenly distributed between all sites did he not? That was a direct response to AF's article stating foreign site corruption. Did Shan lie?
Follow the ATM monies.
“Make the lie big, make it simple, keep saying it, and eventually they will believe it”
“How fortunate for leaders that men do not think.”
Did you forget about this article?
http://www.vanityfair.com/politics/features/2011/01/deadly-medicine-201101
Finally—a significant plus for the drug companies—the F.D.A. does so little monitoring that the companies can pretty much do and say what they want.
You shareholders were lied to again and again. Investigation turned to "Review", ATM activation when they said there'd be none, survivors with no physical proof, BP's in the wings, annual meeting at HQ. ...All a ruse to get their $14,000,000 +/- and capitalize on past ATM's.
Follow the money.
I don't know how they're going to look you all in the eye.
My opinion, of course.
Notice how it went from an "Investigation" to a "Internal Review".
Zero accountability.
If the only investigation is an internal investigation than there are no legal issues to stop from speaking or having questions at the AM. These guys are giving you all such a run-around. It's really near madness.
ASK FOR PHYSICAL PROOF OF LONG TERM SURVIVORS.
At the meeting you must ask them for this. There is nothing holding that information back from you, not the "investigation", not anything! Demand it people!
"Would they have done this if there was a partnership in the near future"
The answer, of course, is NO. And what makes you think the ATM is over with? THey have an open spigot and probably see anything above 40 cents an opportunity. Come on people -Wake up!
Data from other trials is far too small a sampling to have any weight, assuming the results are positive. Never mind that they won't be believed anyway.
DEMAND PHYSICAL EVIDENCE OF LONG TERM SURVIVORS! It's all you have left.
Cotara- "The company plans to seek partners"
Goodnight.
Dilutive ATM Candy store wide open again for salaries and bonuses! Down play urgency of Pll mishap and let it just fade away. Notice their new stated goal and the lack of 3rd party or FDA involvement. So now the goal is to understand our errors and make sure they don't happen again. Do you get the feeling you'll never hear much about this again?
<<The goal of this review is to gain a thorough understanding of the events leading up to, including and following the patient treatment group assignments and investigational drug coding and distribution. This review includes the testing of investigational product, patient samples, reviewing the operations of multiple vendors, among other activities.>>
B. Criminal Prosecutions
A disqualification does not preclude initiation of criminal proceedings against
an investigator. Those investigators referred for criminal investigation are
generally clinical investigators who have knowingly or willfully violated the
regulations or statutes.
(c) Determine whether the studies involving the investigational drug or
device may continue.7 If the Commissioner determines, after
unreliable data submitted by the disqualified investigator are
7
FDA may determine that further use of the investigational product should be suspended at the
investigator’s site (or a more broad suspension, depending on the circumstances). However, if this
suspension could create a life-threatening situation for a subject under the disqualified investigator’s care,
FDA may permit that subject to continue to receive or use an investigational product. Matters where a
subject may be at risk if the study is suspended, among other relevant matters, may be brought to the
agency’s attention during the regulatory hearing.
7
Contains Nonbinding Recommendations
eliminated from consideration, that the data remaining are inadequate
to support a conclusion that it is reasonably safe to continue the
investigation, the Commissioner will notify the sponsor who will have
an opportunity for a regulatory hearing under 21 CFR part 16. If a
danger to public health exists, however, the Commissioner will
terminate the IND or IDE immediately and notify the sponsor of the
determination.8 The sponsor will then have an opportunity for a Part
16 regulatory hearing to determine whether the IND or IDE should be
reinstated. (21 CFR 312.70(d) and 21 CFR 812.119(d)).
(d) Determine whether the continued marketing approval of the product is
justified (e.g., any approved product for which the investigator’s data
were pivotal to FDA decision-making). If continued approval is not
justified, the Commissioner will proceed to withdraw approval in
accordance with applicable provisions of the Federal Food, Drug, and
Cosmetic Act. (21 CFR 312.70(e) and 812.119(e)).
understands that a sponsor cannot disclose for-
eign records that are prohibited from disclosure
by foreign law. Never theless, if the agency be-
lieves that access to records is necessary to verify
certain data or to validate the study and such
records are not available because of foreign law,
the sponsor and FDA will need to agree upon an
alternative validating procedure if the agency is
to rely on the data.
On performing Source Document Verification
The implications of not performing SDV must also be understood. A relatively small
amount of information is collected during clinical trials, which can subsequently result
in massive patient exposure if the drug is process marketed. There is danger of collecting inac-
curate or invalid data from which false or inappropriate conclusions can be drawn. The
rejection of clinical trial data by regulatory authorities can lead to refusal to grant a mar-
keting license and this can have severe time and financial penalties for the company.
These guidelines further state that the
monitor should maintain a record of the findings, conclusions, and action taken to correct
deficiencies for each on-site visit to an investigator. Such a record can enable FDA to
determine that a sponsor ’s obligations in monitoring the progress of a clinical investi-
gation are being fulfilled. The requirement to examine source documents is clearly stated.
KT, Build on your knowledge base.
http://www.diahome.org/productfiles/8357/diaj_12395.pdf
"How exactly do you suggest I get that info?"
PGG, You and other shareholders demand it! At the meeting or through your own legal representation. And I don't mean these bozos suing blindly when they know full well management has a -get-out-of-jail-free-Delaware / Insurance card.
There are smarter people here than I when it comes to the ins and outs follow through after unblinding. For some reason nobody here wants to expand on what the likely trail of evidence is of physical contact with those survivors. Shan saying they exist is not good enough.
This gold standard Pll took roughly two years to unblind
The regimen was for just 24 weeks of dosing.
Standard of care MOS is 6 months
Did most of the long term survivors event during the course of those two years and therefor were never unblinded or studied?
What about the last admissions to the study -are they surviving still? These patients would surely have been unblinded and studied.
Ok PGG, perhaps I was a bit out of line there. But I still do find it curious that nobody here is interested in knowing about the physical evidence of long term Bavi survivors nor the interaction between them and our docs during the last six unblinded months. Not one intelligent reply or question has been raised by what appears to be some very intelligent people. With just a day to go I'd hope that some of you would have formed better questions for the meeting, should you need to go on the attack . I find it odd.
I never said it had to be positive. But yes, I would be suspect of timing either way...But that's just me.
You people really do read too much into things. I'm saying you will not hear anything, imo, BUT if you do, you'd really have to wonder about the timing.
And none of you would find it odd if they unravelled the "coding issue" just in time for the Annual Meeting? Talk about timing!
I told you weeks ago (not months) that you would not hear a thing from our illustrious leaders. That became obvious when "management" moved the Annual meeting. In any event, better security and backdoor escape route for them.
I sincerely doubt many of you that claim to be going to the meeting will actually attend, as it's just a screen to make real shareholders think they're being represented. But if any of you do go please do take pictures. I wonder what this board will be like after the meeting. Depressing thought.