By: SUE32073
24 Jan 2004, 09:26 AM EST
Msg. 136165 of 136180
(This msg. is a reply to 136032 by buckaroobanzai10.)
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Thanks buckaroo! I find your paragraph (as follows) most interesting!

"No, while I stated that other firms also conduct trials in Israel, I do not necessarily imply that ADVR saved money by going to Israel. It has taken over a year already since the Phase I/II trial began; it is a trial of only 30 patients and it should have been completed a long time ago. Clearly, they have had problems recruiting AIDS cachexia patients in a timely fashion, and this indicates poor advance planning. Also, I am not sure how much experience the Selikoff Center (primarily an environmental science/toxicology research facility) has had in conducting and managing drug trials. There are other clinical testing facilities for drug testing in Israel; why was Selikoff chosen?"

Question for you or anyone: If you were CEO of a company, and spent $5 million plus and had successfully gotten an INDA approved, and had successfully gotten past Phase I HPV trials with FDA approval.......(and knowing full-well company money was tight).....(and yet, because Israel trials are "less costly" than trials in the U.S.) decides to take future trials to Israel....WOULDN'T YOU HAVE BOTHERED TO CHECK ON THE AVAILABILITY AND NUMBER OF POSSIBLE CANDIDATES WHICH WOULD BE WILLING TO PARTICIPATE IN THE "COST-EFFECTIVE" TRIALS YOU WILL BE CONDUCTING? WOULDN'T YOU HAVE BOTHERED TO CHECK ON THE MOST OBVIOUS CONNECTION TO SUCCESSFUL CLINICALS ............Patients????

You say it was "poor advanced planning"......I say it was just plain STUPID!!!!!

Your thoughts are always appreciated.


By: lunker10706
24 Jan 2004, 09:55 AM EST
Msg. 136166 of 136181
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More of what I observed is comming back to me in dribs and drabs.
I observed 2 temperature controlled stainless units with small ampules w/blue caps in each. Andy said that each unit is set at a different temp to show the FDA that AVR118 survives at both high and low temps. He said they are reporting to the FDA that AVR118's official shelflife is two years. He did intimate to us that the stuff in reality lasts for years!
We were shown vats of water that are purified by several processes and that ultimately the water is stored in another vat labled WFI (water for injection)
Andy said water from the Bahamas plant was not pure enough, hence the drug used by the Canadian firm could never pass FDA muster.
What amazes me about the way the drug seems to work is that it actually works on the body not the disease.(Laymen's terms folks)
They believe the drug causes the bodies own immune system to
fight off whatever desease or illness has reared it's ugly head.
The other thing I gathered from the slide show and what the scientist said this drug is extremely tough in the body. It doesn't break down like other same type drugs.Which is one thing that has them very excited along with the lack of toxicity.They believe AVR118 is very unique in that regard.

Well if more info seeps back into this brain of mine, I'll be posting it.

By: lunker10706
24 Jan 2004, 10:59 AM EST
Msg. 136173 of 136181
(This msg. is a reply to 136172 by Chrisdez.)
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Chris: My take on the whole Dr. H. thing:

I think Dr. H knew he had a unique drug with a very big opportunity and potential. He probably didn't want to relinquish "his baby" to anyone. He wanted to bring it to market himself,IMO. It's probably just a fact of life that intellectuals on his level are so consumed with the science end of things, they rarely have the business savy to do anything about it.From what I have gathered, it is a monumental task getting a drug through the FDA process. Alot of companies I assume just throw their hands up and say forget it, it's not worth the hassle, time, research, money etc....
I do think this all boils down to funding and more funding. The drug and it's effects speak for themselves.IMO
By: lunker10706
24 Jan 2004, 11:10 AM EST
Msg. 136174 of 136182
(This msg. is a reply to 136171 by FoxChase1803.)
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Fox: I almost felt sorry for him.

He seemed so humbled as we were shaking his hand.You know I can sympathize with many here that have lost money and have been waiting and waiting. I was one of them 5-6 years ago that was frustrated.However after taking the tour, taking in the slide show, seeing that framed pledge on the wall dated 1996 and listening to Eli who I feel on the surface is a very honest, financially learned person, I really feel good about what they are trying to accomplish. If they succeed, WOW!
At that point I won't have to worry about writing that Number one song!

By: Chrisdez
24 Jan 2004, 11:35 AM EST
Msg. 136175 of 136183
(This msg. is a reply to 136173 by lunker10706.)
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lunk: I can see your point. Not sure if drug was his "baby" or "meal ticket" to preserve a way of life. Anyone who has been close enough to at least sniff a clinical trial would know what it takes. He should. Which is why his "on the market statement" haunts me as disingenuous. D'Olimpio knows. Also, his never having purchased a share shows me he's a bit more savvy than the rest of us. My fault, though.

I know many folks who are consumed with science. I don't see it here.

It is about funding. The drug and its effects have not spoken. Still unclear to me why Weizmann anecdotes are preferable to peer reviewed abstracts or periodicals.It's not that hard to do. Maybe one day someone will figure out that demonstrated activity (drug) is the required leverage for a successful alliance. I understand that I may be a bit naive in believing that an outcome (any outcome) is desirable. For all I know, the continuation of the game may be all that is required.

Ironically, companies generally dedicate "the hassle, time, research, money etc" to decide whether or not to kill a drug. Some don't have the intestinal fortitude for such a decision.

I own shares and am neither a basher nor pumper, although that is not really my call. It doesn't matter anyway.
We've wasted alot of time. The distant time horizon is a vast minefield of risk. Struggling to come to terms that this is a trading stock. Period.

To use pr terminology, I was gratified by the spate of recent pr's that there is a cohesive business plan. I'm hopeful that efforts to date will pass scientific scrutiny. My cynical side tells me my phone is ringing, you must excuse me, the President's on the other line.

By: jk1550
24 Jan 2004, 11:43 AM EST
Msg. 136177 of 136183
(This msg. is a reply to 136166 by lunker10706.)
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What amazes me about the way the drug seems to work is that it actually works on the body not the disease.(Laymen's terms folks)
They believe the drug causes the bodies own immune system to
fight off whatever desease or illness has reared it's ugly head.
Very interesting point LUNKER................
Folks this issue has bothered me for years now and I would like those with medical knowledge to join in.

When you give a boost to the person's immune system it would make the immune system work harder and more effectively at any diseases or viruses in the human body. Net results.... the improved well being reported in current Israeli study!

How do you design a test for FDA approval specific to RH or lupus?
What if a patient have several auto immune diseases what is the order of priority of the persons autoimmune system?
Especially if you want to prove efficacy against a single minded RA drug which could be very efficient at curing the RA but kills the patient in the long run?
What end points would the FDA accept for such a drug in an RA test?
By: jk1550
24 Jan 2004, 11:47 AM EST
Msg. 136179 of 136183
(This msg. is a reply to 136171 by FoxChase1803.)
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'Tis a shame also how they all beat him up around here constantly, and barely give him credit for anything
This former CEO knew there was a plant tour yet he got there just in time to say goodbye suckers to shareholders!
What is wrong with this pic?
By: Chrisdez
24 Jan 2004, 11:49 AM EST
Msg. 136180 of 136183
(This msg. is a reply to 136177 by jk1550.)
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jk..trial design could deal with need for exclusions regarding patient selection. I thought back in 2001 it was Weizmann's task to describe the immunomodulation of the drug. How would one describe a normal response to an antigenic stimulus which would also make the immune system work harder.

By: jk1550
24 Jan 2004, 11:56 AM EST
Msg. 136183 of 136183
(This msg. is a reply to 136180 by Chrisdez.)
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Thx Chris
This is why I believe we have a real tough fight on our hands at proving the specific abilities of AVR118.