longs...meeting
was a waste of time. stay home and read the web site will do the same
thing. but do apreciate your effort barry. as for she sounds like she
has a plan with advr!!! i was talking to the manager at kmart and she
sounds like she has a plan to. go new boss go advr. - - - - - View Replies » |
Barry, did the people at the meeting seem to be more private investors or possibly with investor groups?? Just curious if we may be attracting any larger interests... Is it possible at some point for you to give us a synopsis of the meeting?? I appreciate any insight u can share...if we continue to dip I may consider adding...(my apologies if you already addressed this) TIA Z |
Diamond* Could you describe your comments a little further?? (except the K-mart part, i get that) :) TIA (Voluntary Disclosure: Position- Long) |
The
new queen wants to present a clean sweep of the old, and to appear to
bring in a new everything. A new website, new consultants. An outward
appearance and a show of change while the same old delays in moving
along with US FDA filings continue. Wilner redid Hirschman's website,
now Elma makes over Wilner's. Wilner spent big bucks on Nowinski and
Guarino and they were touted as the greatest things since sliced bread;
now Elma does so on Epstein and Taylor. More expensive consultants, more
cosmetic changes and yet more delays in FDA filings. The vicious cycle
begins again. We've been there, done that. The company does not need cosmetic changes and more wool pulled over shareholders' eyes. The company needs to get moving with the FDA. Period. To anyone who attended the soiree in Florida- Did Elma indicate specifically when a new filing of a systemic IND application to the FDA would occur and for what indication of the drug? Or when a Phase II topical study on HPV would be started to continue what was left undone in 2002? Did she present her envisioned timetable for company milestones? I hope she did. We need more than a pleasant and articulate CEO - we need a CEO who makes strategic decisions, can defend them, and move forward expediently with them. - - - - - View Replies » |
HIV/AIDS
Vaccine For Healthy Individuals Tested For Safety, Tolerability 2004-05-03 A clinical trial testing the safety and tolerability of an investigational AIDS vaccine for healthy individuals is being launched this month at the UC Davis School of Medicine and Medical Center. The study, which is part of a multi-site clinical trial, will enroll 273 individuals nationwide. Ten to 20 participants will be recruited into the UC Davis study. Known as a Phase I clinical trial, the UC Davis study will test the safety and tolerability of genetically engineered vaccines that have been designed to protect the body against HIV infection. Developed by Merck Research Laboratories, the test vaccine includes three pieces of HIV known as Gag, Pol and Nef. This next-generation vaccine is based on the use of a non-infectious particle known as an adenovirus. Because this vaccine is produced through genetic engineering techniques, it does not contain any live HIV virus and cannot cause HIV infection. The adenovirus serotype 5 HIV-1 vaccine contains a man-made copy of the HIV-1 gag-pol-nef genes but uses a defective, non-infectious respiratory virus (adenovirus) as a backbone. Like the previous test vaccines, it is designed to stimulate the immune system to develop an immune defense against the HIV proteins. “The goal of this study is to evaluate the safety of this vaccine and to measure the immune system’s ability to respond to the vaccine.” said David Asmuth, assistant professor in the Division of Infectious Diseases at UC Davis School of Medicine and Medical Center and principal investigator of the study. “This vaccine is an expanded version of the previous candidate vaccines designed to elicit a broader, and hopefully, more effective response to HIV. The previous versions were generally well tolerated in volunteers tested and their effect on the immune system is still being tested. Merck Research Laboratories has made a commitment to developing an effective vaccine against HIV and we are grateful to be invited to participate in this important cause.” The trial is a “double-blind” study, with some participants receiving the test vaccines and some participants receiving a placebo, an inactive substance used as a comparison. Neither the volunteers nor the research staff will know which product is being administered. Participants receive the test vaccine by muscle injection. Initial safety and tolerability studies of this HIV-1 adenovirus vaccine were done in animals and several hundred healthy volunteers. These studies have shown the previous versions of the vaccine to be generally well-tolerated. The most common symptoms reported have been injection site pain and headache. Merck is currently conducting several studies in healthy volunteers using the adenovirus vaccine, which has been generally well tolerated to date. Information from this study is still being collected. UC Davis researchers emphasize that this trial involves a test vaccine. They will not enroll anyone whose motive for participation is to use the vaccine as a reason to increase risky behaviors by counting on the vaccine to act as protection against HIV. “Participating in this trial is one way to make an important contribution to HIV vaccine research,” said Asmuth. It will take a sustained and probably lengthy effort to develop a vaccine that stops HIV in United States and around the world. This trial is an important step in reaching that goal.” --------------------------- TO PARTICIPATE IN THE STUDY, volunteers must be healthy males or females between the ages of 18 and 50 who currently are HIV-negative and at low risk for acquiring HIV infection. Individuals who are pregnant or nursing, or who have hepatitis C or hepatitis B infection are not eligible for the study. Study participants will visit UC Davis Medical Center 20 times over an 18-month period to receive a series of three vaccine injections and then will be seen briefly an additional 4 times over the following three and a half years (5 years total). Blood and urine samples will be taken and other tests conducted at regular intervals. All volunteers will receive extensive counseling that will focus on reducing the chance of becoming exposed to HIV. For more information about enrolling in this study, contact Tammy Yotter, study coordinator, at (916) 734-0591. |
Z..the
huge hoopla about a new boss coming she came and the pps went down so
till she shows me the $$$$ and pps is at .50 or higher and HOLDS she has
done nothing. so i daytrade some advr stock till then. ps. im very pro advr but fact is fact and after 20 years were at .135 even with the new boss |
Hi
All,This report is from the Yahoo BB....Aven1 From: cherkassypocket Date: Mon May 3, 2004 12:10 am Subject: CEO Presentation and Meeting with Shareholders went well ADVERTISEMENT I attended...about 20-22 people were there in the audience. Eli Wilner, former interim CEO was there too. She sounded articulate, driven, and accomplished. Major points were: --two to three months before an INDA to be filed in the US for eventual Fast Track (Fast Track means something terminal. READ: HIV and/or Cancer) --ASCO meeting could be significant for the company --She had spent months on doing DD on the drug prior to accepting the position --Between Epstein, the new Chief Scientist, and Hawkins they have dozens of INDA's they have been involved in . --No interest in doing a reverse split at this time. --Expect more communications from the company--but Press Releases will be restricted to just new material information. Quarterly conference calls with the CEO are planned. Frequent updates of the website also. --General tone--- She is very excited about the prospects of AVR 118 and can see it has the potential to be a blockbuster drug in terms of size of market and number of indications. --Hope this helps some out there. (Voluntary Disclosure: Position- Long; ST Rating- Strong Buy; LT Rating- Strong Buy) - - - - - |
So
an IND for systemic use will be filed in July/August? Wasn't the next
shareholders' Yonkers site visit scheduled for July? Elma should have
the full scoop on the IND filing at that time, so we can hold her to it
and ask the right questions. |
I
think we sometimes get trapped in our own way of thinking. I admit I am just that here. I would like some to explain to me the bright side without referring to the future by using words like, could, might, if, perhaps etc. I remain hopeful but find it hard to see a bright side at this very moment. Perhaps in a few months if the Israeli results are good, or we get a partner or maybe Bill Gates will really pony up. Then again maybe the FDA will let ADVR use the Israeli data. Then there is the possibility of fast track status. So much to hope for. (Voluntary Disclosure: Position- Long) |
OUR..
One of the things she stressed is the importance of the Co regaining its
credibility. This was mentioned a number of times. I was very impressed
wth her focus on getting the drug approved for an indcation as soon as
possible. - - - - - View Replies » |
Here
is a snapshot from a poster on yahoo that was reposted here. --General tone--- She is very excited about the prospects of AVR 118 and can see it has the potential to be a blockbuster drug in terms of size of market and number of indications. Sounds very good and very encouraging but after all these years of waiting and a pps of 14 cents or so we have a new CEO that joins many of us who share her thoughts. "She is very excited about the prospects of AVR 118.... me too! "...and can see it has the potential to be a blockbuster drug in terms of size of market and number of indications." ME TOO! But then again I was excited when, We were told the Product to market line. We were told the HPV trial was going ahead. We were told about our quality investors. We were told to expect Israeli results within a year. It is very hard to deny progress has been made. I believe the market usually gets it right. The wisdom of the market values that progress at about 14 cents. That wisdom has the hindsight of her remarks yesterday. 12:16 P.M...VOL 295,266 with last trade at $.141 goo ooo ooo advr |
nvphyl,
I understand that most longs on this board are frustrated with the slow
progress, but this formula not only had to be revamped a few times to
keep up with the new findings regarding the immune sstem over the past
few years, but also had to win-over the FDA after years of screwing
around with false claims. These false claims were probably related to a
gut feeling on the part of scientists that the immune system could be
altered or enhanced by this drug. They lucked out when the formula was
not harmfull, but the true science of this formula has not come to light
till very recently. I must say that if the drug ever came out again
before the true science ws done then the competetors would have found
the formula we now have and prospered. Thanks, Mike (Voluntary Disclosure: Position- Long; ST Rating- Strong Buy; LT Rating- Strong Buy) |
Mike, You are right as far as I am concerned. Much work has been done and patent protection is important. Now we need to get started with the FDA asap. I look forward to the completion of the Israeli Trial. IMO The next level of investigation should help the pps. We have played the name game here to no lasting benefit. I must admit from the reports from the Florida meeting Dr.Hawkins sounds like she may be in the right place at the right time. Let's hope so. jim (Voluntary Disclosure: Position- Long) |
trouble4u4:
"Who is 'gator??? " you ask? Let me tell you Well, Gator is a long time supporter of ADVR who was always tos'd by a little cult here for the same things they do themselves. As well, any SUPPORTER of ADVR, who supports the Company TOO much, also gets Tos'd for whatever reasons they want to fabricate. They get away with it because they have the 'Tos in numbers' with many aliases and also as is said: an "in". So be careful. You may not even see me here tomorrow. Good luck! Luv - - - - - |
Did
Elma indicate at the Florida meeting if all 30 patients are now enrolled
in the Israel trials and when the results of those studies can be
expected ?
|
Dick,
To understand how peptide nucleic acids become an analogue of DNA is too
complex to make any sense, but it seems that AVR 118 which is in this
class is showing multiple uses in not only the destruction of unwanted
cells, but also the protection of cells that are hurt by other drugs.
This is sure to be the next Pennicilin of our time. I do not know how
many discoveries will come from this science, but I do know that we are
the nearest to market of his new form of therapy for many ailments. AVR
118 is a FREAK in my opinion. I find it hard to understand how this
company found an immunomodulator that will switch from destroyer to
protector, let alone the lack of human toxicity. My investing in ADVR is
based on the fact that I know this new treatment is the future, and it
is well worth the chance to get in early. Remember that there are many
formulas that could not be protected by patent once ADVR lets the cat
out of the bag and all these other companies add or subtract a molecule
here and there to name their own new drug. Thanks, Mike (Voluntary Disclosure: Position- Long; ST Rating- Strong Buy; LT Rating- Strong Buy) |
shemp1248
My Father thinks AVR118 will be the 1st. of it's Class
Marketed(injectable)...i agree with you,sorry about my previous
remarks.. DICK |
My
plans are to SELL 1MIL. SHARES AT 1.50+ AND HOLD A MIL. FOR 5
YRS....When AVR118 hits the Market PPS $20--35 imo DICK |
Does
anyone have a email address for Dr. Hawkins? I have several questions
for her regarding AVR118 and also her plans with ADVR in general. Also, can anyone give me an overview as to how the meeting went and some insight regarding filings or results of the final 15 patients? When will the results be announced? Is it reasonable to expect filing for a fast track status within the next 6 months? Thank you. |
Hey,
Keith0228 The way I had a gap described to me (I had asked the same ? ur askin') is that its like having a Hole in your foundation... My understanding is that the gap can serve as support but you always want it to fill and then move up...that's a bullish sign...I took a class with Steven Nisson who brought candlestick theory to the U.S. and I specifically asked him the "gap" question as well as how small can a gap be?? His response to me was that, "a gap is gap", ie even a few pennies are considered gaps..... Another theory I've heard (it makes sense)is that a "technical" gap (like with advr) always needs to fill, however, a "fundamental" gap does not... If you go to stockcharts.c and look at DNA you'll see a HUGE gap around $30ish range....it came because of FDA approval news....obviously that gaps NEVER likely to fill since thats a huge fundamental shift....(also some idiot put a sell rating on DNA the day before approval ) One last thing, if you look at the post I made to Sue yesterday, you'll see some quotes from the famous trader Jesse Livermore...great explanation as to why charts are valid... Hope this helps, a little long winded.... Regards, (Voluntary Disclosure: Position- Long) |
GREAT
CLOSE EVERYONE!!!!! WHoo Hooo!!! Anyone else have .014 showing up as the low??? It must be a boo boo on my scottrade screen..... (Voluntary Disclosure: Position- Long) |
BarryM....Elma
said that ADVR is currently working on deciding which indication would
give us the least path of resistance with the FDA while also giving us
an indication that does not have many competitors. She would not commit
to topical vs. systemic. They expect to have this all completed and ready to file a new IND somewhere around June/July. All Israeli data and other previous data will be supportive for this new IND. She showed us a triangle shaped picture on PowerPoint with AIDS at the top followed by Cancer and then Rheumatoid Arthritis at the wide bottom. She explained that it would be more prudent at this time to had an indication that would not require a huge patient trial base do to the company's limited financial resources. She believes we need to get AVR118 to market and THEN we can expand the indications and trials which potentially could make AVR118 a "blockbuster" drug! (Voluntary Disclosure: Position- Long; ST Rating- Strong Buy) |
How
much have we invested in Dr Hirschman? About 300K a year for 8 years =
2.4 million and a new set of tires. |
What
is Ampligen?..... Ampligen is a drug manufactured by HEMISPHERx Biopharma, Inc., Philadelphia, Pa. It is an antiviral and immune modulatory drug under the nucleic acid class of drugs (NAs). Nucleic acid drugs are designed to mimic the body's own digitalized informational molecules (called DNA and RNA) which, in some laboratory and animal studies, reprogram certain diseased cells to enhance their intrinsic disease capabilities. To date, HEMISPHERx and its subsidiaries have received over 200 patents internationally to protect its proprietary position in NA and related drug technologies ********************************************************* FYI.....-kevtod |
Barry
it sounds like we are going back to square 2 with Israel data to cover
for square one for U.S.A.trials How close could we have been to square
(phase) three had we stayed with the topical for hpv. It almost sounds
like our former leaders sufferer from adult attention deficit disorder.
I'm not picking on you. I'm only venting at the info you provided. And
Elma is only picking up the pieces to try to make this work.What
leadership we had. - - - - - |
BarryM....Elma
said that she and her staff has been going through every piece of paper
that is stored at the Yonkers facility. All data is being logged. She
prides herself on taking the time to do things the right way the first
time. Basically, an IND is a lengthy application. ADVR has a wealth of data to complete it. Once Elma and her team decides which indication will be filed for, then the data is inserted in the application. The FDA has 30 days to respond...yea or comments. From what I heard from Elma about both her work ethic and her staff, the application should be perfect the first time. Therefore, it should be no problem filing in the July/August time frame. It could be done today but they are not yet decided of which indication to file for. Also, keep in mind that ADVR already has Phase I data so we should get permission to go to Phase II promptly. (Voluntary Disclosure: Position- Long; ST Rating- Strong Buy) |
To
addto barry's info.. the object is to do an ind to get approval to
market asap. |
sardti...you
are probably 100% correct. ADVR had amateurish leadership under
Hirschman. What experience did he have in getting a drug through the
FDA? He basically was learning as he went, on the backs of shareholders.
Unfortunately, it took years until major shareholders (Wilner/Harborview)
got pissed off and insisted on changes. IMO, Hawkins will move methodically with lightening speed compared to the bungling idiots of the past. She will not change course in midstream like Hirschman did with Argentina / HPV Phase II /Israel trials / etc. She will set a goal and not rest until it is achieved! Hawkins and her staff have the experience. If I remember correctly, she and her staff have filed about 70 IND's and taken 7 drugs to FDA approval. IMO, AVR118 will finally get FDA approval under her stewardship and our market cap will rise greatly as we get closer and closer. (ASCO.....shhh!) (Voluntary Disclosure: Position- Long; ST Rating- Strong Buy) |
As
of December 31, 2003, Dr. Hirschman held (a) options to purchase
4,100,000 shares of common stock at $0.18 per share; (b) 4,000,000
shares of common stock at $0.19 per share; (c) 4,000,000 shares of
common stock at $0.27 per share; (d) 4,000,000 shares of common stock at $0.36 per share, and (e) 23,000,000 shares of common stock at $0.27, all of which are currently exercisable. Shares exercised & held = 0. ********************************************************* IAG....-kevtod |
mb-
In this case, ASAP = Approx. 5 years...eom |
Barry,
I want to ask you a simple question, WHY would ADVR/Hawkins choose to
start all over again with a NEW IND, when ADVR ALREADY has been given
the go ahead to move into Phase II testing with HPV?? - - - - - |
bb-
Perhaps a choice has already been made...eom |
Kev
strop being sarcastic.. I believe whe was talkingfew months.. She would
not give a date but indcated sometime this year. Have patience, we have
a real leader to take us to the pomised land. I totally believe in her
and her straight forward answers to all that was asked. |
Bernie...she
was asked that question. Her reply was that topical HPV might not be the
best route to get AVR118 to market but she would not rule it out either.
I tried to press her into revealing the indications under review but she
politely refused to tell the group. Hawkins is a master planner and
tactician and when she makes up her mind it will be well thought out and
she will blast forward expeditiously! (Voluntary Disclosure: Position- Long; ST Rating- Strong Buy) |
Our..
When asked that question, her reply was that there are two drugs on the
market now for that indication and it is unlikely the FDA would fast
track another one. She is looking to fast track. I hope this answers ur
question. |
"Have
patience, we have a real leader to take us to the pomised land." I can remember you saying the exact same thing in 1996 when you and Friedland brought SZH aboard. And were JUST as enthusiastic about HIS ability to take us into production for retail sales. Answer me this, has ADVR shelved the HPV approval for Phase II studies in the USA, in favor of beginning over again with a new IND? Does your lawyer (and ADVR's management) say it's ok for you to post here on the RB board publicly, when most here know you are indeed Bill Bregman? |
Our
.. When we hired szh, we were without answers to many questons that the
FDA wanted answers for. There was a need for original research to go
ahead. That was done wth a very fine research dept with over a million
in machinery and equipment. We were thenin need of someone to advance us
further. Eli found Elma and we are nw forging ahaed. Since I donot
reveall inside info, free speach is allowed. I am happy with his
selection... |
"
that there are two drugs on the market now for that indication and it is
unlikely the FDA would fast track another one. She is looking to fast
track. I hope this answers ur question." ----------------------- And so, let's play the "what if" game:: What if she decides to put money and effort into submitting a _new_ IND for systemic AVR118 with "fast track approval" and the FDA says "no fast track??" That puts us back to square one and once again behind the 8 ball. You are making assumptions, as usual Bill, that all will go perfectly as planned. As we have learned from ADVR 101, very little goes as planned. And in the happenstance that the FDA chooses to deny fast track approval, we have been sitting on and IND approval, a Phase I approval with a shelved Phase II go ahead by the FDA. My point being, who cares that there are already 2 applications for HPV on the market, the objective is TO GET SOMETHING/ANYTHING TO MARKET EVEN IF IT IS ONE OF MANY. ADVR's dilemma has ALWAYS been they have _never_ gotten close to having ANY FDA approval for sales of ANYTHING. The effort of completing an already started project and moving it into the marketplace TRUMPS any new IND for any other indication. They could start that RIGHT NOW> TOMORROW if they chose to. What if ADVR put out a PR tomorrow that they have moved into Phase II and are now recruiting patients HERE IN THE USA as previously approved of by the USA FDA and will begin testing within one month. What do you think THAT would do to the PPS - instead of hoping the PPS will go up for an ASCO conference (which is going to happen ANYWAY). And with that PR they say, ADVR is also planning on submitting an IND for systemic use of AVR118 within 3 months. How would THAT PR help the PPS, over the top I'd say. And with the rising PPS, in comes more shareholders and potential suitors!!! Once you've gotten the drug into the marketplace, you will gain recognition and can advertise etc. ADVR should place SOME value on trying to raise the PPS, which an approval for sales here in this country WILL do. Are we once again going to try to push the river, so to speak, instead of taking what is already ours and move WITH the river downstream?? Why is it ADVR always takes the MOST circuitous route toward success, when the vision is RIGHT THERE IN FRONT OF US. Like canceling the cancer mitigation studies in Israel. There is something wrong here in the thinking process at Yonkers. Someone there needs to THINK BIG, instead of small timing it - like Hirschman did for 8 years. |
Our..
The FDA is not an isolated gov agency that does not have discussions wth
DRs. The time now is taken with deciding which will get us there the
fastest. HPV was discussed, debated, and notedthat maybe a change in the
ind dwould be helpful. As of now a great deal of time is used reading
papers in the office since that is the only way of knowing what
happened. No decission has been made. All answers will be awithoutr
speculation. I am sorry u werenot able to attend, but conference calling
is in the picture and that may help u in understanding what is goling
on.. Getting thoughts second hand wthout hearing the back and forth does
leave u with an incomplete understanding. This is a new era.wlth a
qualified leader and staff that has gotten my trust. I have no warrants,
or am, recieving no renumerations from the co. My hope is this product
comes to market at the earlest time. The world has the need. - - - - - |
Bernie...when
Hawkins was asked about Fast Track she said that the way to do it is to
put together a great IND that in turn makes the FDA ask: "shouldn't
this be Fast-tracked?" The game is to get the FDA on your side. The
FDA is not the enemy. They want things to go smoothly....it makes their
job much easier. Remember, Hawkins has been there many times before.
Where has Hirschman been??? Hawkins is a genius and I wish you could speak with her one on one. Hirschman comes nowhere close to her capabilities. Btw, she will not hype the PPS by announcing Phase II HPV and not go through with it. (Voluntary Disclosure: Position- Long; ST Rating- Strong Buy) |
With
you online and us knowing who you are, I would hope you would enlighten
some here (within the confines of legalities) as to past events and -
without promoting extensively - lend us an understanding of some of the
history and inner workings of how we got here. Thanks for your unfettered participation here. |
No
matter how it goes, no matter which choices are made, my affection and
support of all ADVR shareholders is unabashedly positive. Good luck to all and here's to a rising PPS shortly up the road and riches to all. |
mbengineer....Holy
smokes, I never really thought you were the former founder and former
member of the BOD of ADVR -- Bill Bregman. I have to tell you, it feel
really weird having you post on ADVR Stock Message Board. You really
have got to be walking on eggs - each and every time - you make a post
on here. Did you not sign a Confidentiality Agreement during your time
with ADVR? I know you mentioned your "right" to have Freedom
of Speech and do as you will since you are not RETIRED. But, the fact
is, YOU STILL OWN A CONSIDERABLE AMOUNT OF ADVR SHARES - whether they be
in your name of in the name of other family members. What is YOUR purpose of posting on this rather insane message board? I'm not sure I can come up with a legitimate answer --- I'M STILL IN SHOCK FROM YOUR REVELATION!!!! P.S. I haven't had a chance to read any of the messages posted last night after your Revelation Post -- I still catching up on here! Sue |