| OT:
More on Naked Shorting: USXP vs. SEC Universal Express Questions SEC Actions Thursday April 1, 8:30 am ET NEW YORK, April 1 /PRNewswire-FirstCall/ -- Universal Express, Inc. (OTC Bulletin Board: USXP - News) President & CEO, Richard A. Altomare, stated, "It's a classic David vs. Goliath case. We have respectfully waited without response from the SEC to the lawsuit we first filed against it for unconstitutional abuse of the powers given to it by Congress. In the meantime, the SEC resorts to negative publicity by attacking us in the press, rather than using the federal court system to determine the merits of our complaints. It also resorts to the highly unusual, if not improper, action of filing its own lawsuit against us in New York, rather than in the same federal court where we filed our lawsuit first. "The SEC's accusations against our Company, its Chairman, its General Counsel, and numerous outside consultants that courageously helped to build this fine Company during naked short selling attacks, are unfounded. The SEC seems intent on maligning the messengers and assisting the naked short sellers by creating negative press on our Company more than defending against our accusations filed in the Miami federal court. "This case will be heard in a courtroom, not in the media. Unlike the SEC, Universal Express has not inappropriately resorted to news releases detailing our complaints of rogue agent interference, collusion, SEC improper behavior and unconstitutional conduct, nor will we. We will keep faith with our judicial system and prove the misconduct in our lawsuit, rather than pontificate to the press. "When we filed the initial lawsuit, USXP had presented over 50 formal quarterly and annual reports, and hundreds of press releases without review, question or comment by the SEC. We went without even a letter of reprimand or phone call for 14 years. We ask the public and our supporters: don't you think it untoward that, only days after our lawsuit against the SEC is filed and made public, USXP was accused retroactively for press releases, fundings and quarterly contents, and whatever else the SEC hopes will deter others from questioning its unregulated authority and joining in on our fight to outlaw and ban the naked short selling of publicly traded stocks? "We stand behind our lawsuit. Despite the SEC's inappropriate accusations, improper behavior and inappropriate and unfounded response against one of the smaller developing public companies, we will wait until the case is heard," Mr. Altomare added. "According to the SEC, billions of shares of this company's stock have traded. If that trading happened because of one or more press releases or funding, as the SEC alleges, where are the certificates, we rhetorically ask," posed Mr. Altomare. "When all is said and done and all of the SEC documents to be produced are disclosed, the truth, not character attacks, will be told. "Seemingly undefeatable adversaries are often defeated by their own actions. Our trading system relies on the professionalism and consistent objectivity of its regulators. When did our regulators become participants in the scandalous process of naked short selling by endeavoring to intimidate its critics by resorting to verbal hostility, unfair utilization of the press and invoking fear? "Universal Express is a popular and innovative developing company that would have benefited from the on-going regulatory guidance of the Security and Exchange Commission during our growth. Whenever we called the SEC for assistance against naked short sellers, we were ignored. After our two consecutive successes in court against naked short selling schemes tied to other fraudulent conduct -- totaling over $526,000,000 -- we became an SEC target. All the SEC power and legal strength will not drown out the overdue voices of American shareholders and developing companies, trying to create American jobs, while being hurt by a regulatory trading system that is not protecting its developing companies. This time, a court of law will hear words of those victimized by the scandalous schemes and the even more scandalous ignoring of those schemes by the SEC. That's the case. Plain and simple," concluded, Richard A. Altomare. |
| Sue-
Although the claim is/was that the Bahamas plant was up to par on FDA
requirements, the plant was never inspected or FDA certified. Had the
HPV topical trials continued, and the product continued to be
manufactured at the Freeport plant, the FDA would have most likely
inspected the plant before Phase II, but certainly before Phase III. I
did have communication with the FDA on this point, and that is what I
was told by them. I probably still have the documentation if required. (As a side note: We have been "currently negotiating the sale of the Bahamian facility" since December 2002.) Although the timeline for inspection of the Yonkers plant wil be set by the FDA, it is not unreasonable to presume that they would apply the same standards to Yonkers as they did to the Freeport plant..... Hope this helps.... IAG......-kevtod |
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| After
speaking with ADVR's IR/PR people, the company says that all the
information in the 10-K is factually accurate and they continue to stand
by their statement that the trial in Israel involving cachectic AIDS
patients will be completed during the 2nd quarter [April 1 - June 31]
2004. IMO, this means one of two things: 1. ADVR believes they can still recruit and complete testing of 7 more patients during the present fiscal quarter, or 2. ADVR will complete and report on the trial with less then 30 patients enrolled. Kevin (or anyone else who knows anything about clinical trials), is it possible to complete the trial without recruiting the full 30 patients. For example, if we were to assume that all 23 patients enrolled responded positively to the AVR118 treatment, could ADVR complete/end and report on the trial since whether it is 23 out 30 or 30 out of 30 patients showing efficacy, statistical significance would have been achieved? Or is this just not realistic? |
| Funny
stuff, in a way. The Freeport plant was never inspected or FDA
certified. Doesn't this mean that every one who has ever been injected
with Reticulose/AVR118 has used product that was manufactured by a non
FDA certified manufacturing facility. Everyone! With no reported toxic reactions! Everyone, even those cancer patients treated by Dr. D'Olimpo at Northshore. Everyone, even those 23 patients involved in the Israeli trials. Yes, everyone who has ever ordered product out of Canada. Why? Because the people associated with Reticulose have know for years [≈70] how to manufacture an effective, non toxic and sterilized product. They've known well before any bureaucrat even had a glimmer in his eye for the establishment of an FDA. |
| Shaggy.,
This drug will end up producing multiple indications for the medical
folks to ponder when treating patients. I think the key here is to have
a clear understanding of what the FDA will need to get this drug off and
running. I feel that the scientists working anywhere near this formula
have concluded this switch-type immune system drug can and will be not
only helpful, but safe. I would love to know how many shares are owned
by family members of the FDA employees closely tied to the progression
of ADVR's progress. I am not the only person in the medical community
that feels this drug is the next huge blockbuster, and this could be the
reason ADVR is holding off from asking a bigger company to join up. This
formula will be available to doctors very soon and the question will be
how the company can maximize their financial potential. Instead of
letting the doctors have one drug with many indications, they may choose
to alter a molecule or two and send out multiple drugs with different
trade names. This can be done without any changes in safety or
efficiency, and allow for the Oncologist to treat their patients, and
the Neurologist to help their MS patients with different trade names
from the same company. I would think ADVR is setting things up this way
and has communicated this with the FDA in order to avoid problems once
this drug is an OK. I am hoping this is the reason for the delays and
irregular path this company seems to take at times. The path ADVR has to
take is unique in that most small Biotechs. find a formula that is good,
but has finite indications with a few side effects, and the larger Pharm.
bring their drugs to market without much hype since they are already big
and have multiple dollars and products. ADVR is comming out of the
closet with a huge formula that has an infinite potential, and may push
this company way up the ladder. Thanks, Mike (Voluntary Disclosure: Position- Long; ST Rating- Strong Buy; LT Rating- Strong Buy) |
| Shag-
It is quite realistic. The trial is complete when ADVR says it is
complete. There is more than ample precedence for ending a trial prior
to meeting the original protocols intended quota. It goes without saying that the larger the trial, the more weight that can be given to the statistical significance. As far as using the data in support of an IND to be filed with the FDA.....more would be better. I know that it sounds odd, and I'm sure that someone with much more experience & knowledge will try to correct me, but 6 out of 10 is not the same as 60 out of 100, which is not the same as 600 out of 1000..... But, I'm sure that none of this will matter, because AVR118 is sure to be 100% effective 100% of the time.....TIC..... FWIW- The company can, in good faith, claim that the trials are on schedule right up until the 31st of June.....What they are not telling us, (although I did see some mention in passing), is that the extrapolation of the data will take several months beyond that..... So, I remain a happy camper wherein my expectations of published Phase I/IIa results out of Israel will be forthcoming by January 2005. Anything sooner than that will be a bonus in my book...... Best to you & your son Shag, miss sparring with you..... It's All Well & Good.....-kevin |
| In
the 4/9/04 AIDS article titled "Granule-dependent mechanisms of lysis are defective in CD8 T cells of HIV-infected, antiretroviral therapy-treated individuals," Trabattoni et al. (Mario Clerici is senior author) state: "Thus, ART fails to restore HIV-specific CTL; moreover, the activity of HIV-specific CTL decreases after ART-induced suppression of HIV. This results in a rapid rebound of HIV replication upon interruption of ART even in patients in whom plasma viraemia had been undetectable for prolonged periods of times. It is nevertheless strong in HIV-infected long-term non-progressors in whom viraemia is low but detectable. A potent HIV-specific CTL response is also detected in asymptomatic HIV-infected individuals who have chosen not to undergo ART but nevertheless control viral replication." "We performed the same analyses in CMV-stimulated PBMC and observed that reduced perforin and granzymes expression and synthesis are also detected in CMV-specific CD8 lymphocytes. These data reinforce the idea that CD8 defects are not antigen-specific but rather are associated with ART." "Why are CTL defective in ART-treated individuals? The observation that the low perforin-expression CD8+/27+/28- are only slightly increased in treated patients does not justify our results. An alternate explanation is that antiretroviral drugs directly interfere with the synthesis of perforin and granzymes. Preliminary data obtain by culturing in vitro PBMC of healthy individuals with antiviral drugs suggest that this mechanism is probably involved in CTL impairment. Additional data obtained in HIV-exposed health care workers undergoing ART-based prophylaxis, show that perforin and granzymes are reduced in CD8 T lymphocytes after 1 month of therapy (M. Cleric, et al., unpublished results). The small number of individuals examined did not allow us to verify whether these effects are associated with any particular drug regimens (e.g., PI versus NNRTI). It will be of interest to verify if such correlation exists in larger cohorts of patients." "It was assumed that ART-induced HIV suppression would be associated with immune recovery, allowing immune control over HIV replication. The evidence that HIV rebounds once therapy is suspended negates this theory. Our data demonstrate the presence of a functional impairment in CTL of ART-treated patients and provide a rational basis justifying the lack of immune control over HIV replication observed even in successfully ART-treated individuals." ----------------------------- Trabattoni D, Piconi S, Biasin M, Rizzardini G, Migliorino M, Seminari E, Boasso A, Piacentini L, Villa ML, Maserati R, Clerici M. Granule-dependent mechanisms of lysis are defective in CD8 T cells of HIV-infected, antiretroviral therapy-treated individuals. AIDS 2004 Apr 9;18:859-869. Department of Immunology, University of Milano, Milano, Italy. Abstract: Background: HIV-specific cytotoxic T-cell (CTL) responses are defective in HIV-infected patients undergoing antiretroviral therapy (ART). This defect has been attributed to the decreased antigenic burden secondary to ART-associated suppression of HIV-replication, and is responsible for the rebounds of viraemia that occur when patients interrupt therapy. CTL are stimulated by type 1 cytokines and can kill targets via granule-dependent (perforin and granzymes) and -independent (tumour necrosis factor-alpha, CD95) mechanisms. Methods: Granule-dependent and granule-independent mechanisms of CTL killing, as well as type 1 cytokine production by CD4 T cells, were analysed in 57 chronically HIV-infected ART-treated or ART-untreated individuals. Results: The results can be summarized as follows: the frequency of gp160 (env)-specific interferon-gamma-secreting CD8 T lymphocytes correlates positively with HIV viraemia in ART-treated and -untreated patients; Env-specific perforin- and granzymes-expressing CD8 T lymphocytes, and Env-stimulated perforin and granzymes mRNA, are reduced in ART-treated patients independently of HIV viral load and of type 1 cytokine production; tumour necrosis factor-alpha production is increased in ART-treated individuals; and Env-specific immature CD8+28+27+ cells are only marginally augmented in ART-treated patients, Similar results are observed in cytomegalovirus-specific CD8 T cells and peripheral blood mononuclear cells. Conclusions: A defect of CTL function that selectively affects the granule-dependent mechanisms of lysis is observed in ART-treated individuals. Because interferon-gamma production is higher in these patients, this could be a defect primarily involving CTL. These data suggest an independence of CD8 T-cell numbers and their lytic ability in HIV-infected, ART-receiving patients. Immunomodulants are needed to successfully treat HIV infection. |
| Hi
Kevtod,....."Immunomodulants are needed to successfully treat HIV infection. Well I am surely no Rocket Scientest but isn't this where AVR118 comes into the PICTURE!!.......GO GO GO ADVR....Aven1 |
| From
OTC News Alert: NASD Regulation 3370 Goes Into Effect Today: Illegal Naked Shorts on the Run For those of you who have been following this issue, I have an update. If you see some Bulletin Board stocks begin to trade a little crazy, it may be the result of this new regulation. I have reported on this issue in four previous editions, and I have learned a new rule went into effect today which appears to be the answer to a problem which has plagued the microcap market for many years. Illegal naked short sellers have been able to funnel trades into US markets through Canadian Brokerage firms to the detriment of many investors. US brokerage firms are regulated by both the SEC and the NASD. Canadian firms are not. NASD Regulation 3370, entitled "Affirmative Determination Requirements" places the responsibility on the US Brokerage firms to determine if sellers who are non NASD member (coming from outside the US) can actually deliver the securities they are selling. If they cannot, the trade cannot be executed on their behalf. The new NASD rule went into effect today, and rumor has it that illegal naked short sellers are scrambling to find a home for their positions. I don't believe they will be forced to cover existing shorts, but for future trading the loophole has been closed. Look for this to have a very positive effect on many microcap stock values. |
