By: SPARKR
26 Jun 2004, 12:45 PM EDT
Msg. 158696 of 158790
Jump to msg. #  
More From 6/21/04 Meet-The-CEO-Meeting

At the meeting Dr. Hawkins touched upon the topic of Drug Development Costs , in general , and that today's estimated average drug devlopment cost to bring the average drug to market in the US is approx $850 Million over a twelve (12) year period , which includes " Discovery ", " Pre-Clinical ", " Phase 1 " ( first 6 years ), and " Phase ll ", " Phase lll " & " NDA " ( last 6 years ),

HOWEVER , SHE ALSO STATED THAT THE $850 MIL AVG COST INCLUDES ALL THE "FAILURES" DRUG COMPANIES EXPERIENCE ALONG THE WAY ,

AND THAT " IT WOULD ONLY COST ADVR A SMALL FRACTION OF $850 MIL TO BRING AVR 118 TO MARKET IN THE US " .

Regarding a timeline , in choosing an indication for AVR 118 for a US IND , any such indication "MUST POSSESS THE CHARACTERISTIC OF BEING ELIGIBLE FOR SPECIAL REGULATORY CONSIDERATIONS ", i.e., fast-track , etc......

ALSO FROM MY NOTES FROM THE MEETING :

AGENDA :
*** WHAT'S NEW @ ADVR
*** GETTING AVR 118 APPROVED
*** THE WAY FORWARD
*** COMMNICATIONS
*** VALUES
*** Q & A

*** WHAT'S NEW @ ADVR
NEW LEADERSHIP WITH EXCELLENT TRACK RECORDS
NEW CAPABILITIES
NEW THINKING
NEW URGENCY
NEW ACCOUNTABILITY
NEW CONTROLS
NEW ENERGY

CEO STARTED FEB 18, 2004 ..... 4 MONTHS
ELMA HAWKINS, PhD, MBA
** Pfizer (Warner Lambert/Parke-Davis)
* Nipent
* Neutrexin
* Amsacrine
** Genzyme
* Epicel, Carticel, Acticel
** Antigenics ( Vice Chairman)
* Oncophage (Cancer Drug)
** Tufts University Center fot the Study of Drug Development

GETTING A DRUG APPROVED :

*** NEED TO SHOW TO FDA SATISFACTION THAT PRODUCT
IS SAFE & EFFECTIVE
*** ON BLACK & WHITE
*** ACCORDING TO FDA REGULATIONS CODIFIED IN 21 CFR
PAR 312
*** LARGE WELL CONTROLLED RANDOMIZED CLINICAL STUDIES
** GENERALIZIBILITY
** REPRODUCABILITY
*** LARGE SAFETY DATABASE AND INTEGRATED SUMMARY
*** VALIDATED MANUFACTURING & SUPPORT ( QC )
*** NDA
*** APPROVABLE / APPROVAL LETTER

IMO , BASED UPON THE 6/21/04 PRESENTATION GIVEN BY ELMA S. HAWKINS, PhD, MBA, AND BASED UPON MY GUT FEELING ABOUT HER , I TRUELY BELIEVE THAT SHE HAS ALL OF THE KNOWLEDGE , EXPERIENCE , LEADERSHIP , QUALITIES, COMMITTMENT , STRATEGY , FDA CONNECTIONS/EXPERIENCE , ENERGY , TENACITY & PASSION TO BRING AVR 118 TO MARKET .

THIS CEO SEEMS REALLY DRIVEN TO ACCOMPLISH HER GOAL !!!

I REALLY THINK SHE WILL DO IT FOLKS !!!

LOL

SPARKR

(Voluntary Disclosure: Position- Long; ST Rating- Strong Buy; LT Rating- Strong Buy)


- - - - -
 

 

By: lovingitall0
26 Jun 2004, 01:34 PM EDT
Msg. 158697 of 158790
(This msg. is a reply to 158696 by SPARKR.)
Jump to msg. #  
SPARKR: I must compliment you on your note taking at the meeting with our Company CEO, Dr. Elma Hawkins. Some can barely read their notes when taken. You seem to be most thorough as well as extremely competent.

You may get the usual considered "smart quips" comments on here. That's not my style or how I prefer to support the Company I'm invested in. I appreciate what I hear, like what I see and also prefer to believe what is said until proved otherwise.

Time now for fun and sun!

Luv, loving it all 'indeed'.
Terrrrrific! Gooooood job! And, THANKS!

I love this part also:

"HOWEVER , SHE ALSO STATED THAT THE $850 MIL AVG COST INCLUDES ALL THE "FAILURES" DRUG COMPANIES EXPERIENCE ALONG THE WAY ,

AND THAT " IT WOULD ONLY COST ADVR A SMALL FRACTION OF $850 MIL TO BRING AVR 118 TO MARKET IN THE US " .

Regarding a timeline , in choosing an indication for AVR 118 for a US IND , any such indication "MUST POSSESS THE CHARACTERISTIC OF BEING ELIGIBLE FOR SPECIAL REGULATORY CONSIDERATIONS ", i.e., fast-track , etc......"

http://ragingbull.lycos.com/mboard/boards.cgi?board=ADVR&read=158696

 
By: SPARKR
26 Jun 2004, 03:26 PM EDT
Msg. 158701 of 158790
(This msg. is a reply to 158697 by lovingitall0.)
Jump to msg. #  
lovingitall0's

Thanks !!!

IMO , the difference between our present CEO Dr. Elma Hawkins and past ADVR's CEO's is that :

Dr. Hawkins' is going full steam ahead with a strategy and a plan of action based on sound principles and realistic goals AND WITH THE KNOW-HOW relating to the necessary sequence of events that are needed to be followed in a certain order , to specifically PROVE TO THE US FDA that AVR 118 is safe and effective ,

while in the past, all testing and results of clinical trials involving Product R , could only at best , be published and offered for review by the medical community in general, with the hope of becoming useful in a US FDA INDA .

THERE WILL BE A HUGE DIFFERENCE THIS TIME AROUND FOR ADVR , IMO !!!

As stated by our new CEO Dr. Elma Hawkins :

THE WAY FORWARD FOR ADVR IS AS FOLLOWS :

*** WE CANNOT UNDO THE PAST - WE CAN ONLY MOVE FORWARD

*** WE MUST BE FOCUSED

*** CHOOSE AN INDICATION WITH EXTREME CARE
** CLINICAL
* MEDICAL NEED ;
* HOW LIKELY IS IT TO WORK RELATIVE TO
PRIOR DATA ;
** REGULATORY
* WHAT ARE REGULATORY HURDLES/ADVANTAGES ?

** MARKET RESEARCH
* WHAT ARE THE COMPETITOR PRODUCTS ?
* OPINION LEADERS, PHYSICIANS, PATIENT
INTERVIEWS

*** CONDUCT CLINICAL TRIALS UNDER AUSPICES OF US FDA

*** CONDUCT PRISTINE CLINICAL TRIALS WITH APPROPRIATE
DATA COLLECTION PROCEDURES .

LOL , ALL GOOD, IMO !!!

SPARKR

(Voluntary Disclosure: Position- Long; ST Rating- Strong Buy; LT Rating- Strong Buy)
 
By: lovingitall0
26 Jun 2004, 03:47 PM EDT
Msg. 158704 of 158790
(This msg. is a reply to 158701 by SPARKR.)
Jump to msg. #  
SPARKR: Again, I must thank you for making more sense here when no sense is appreciated. HOWEVER

One can read the intelligence from one like you than from the other mindless ones here.

Keep it goin' nd keep it flowin'...
I'm going to have to repeat what you say, cause you make sense in a forum where little sense is to be read.

http://ragingbull.lycos.com/mboard/boards.cgi?board=ADVR&read=158701
 
By: crescent40
27 Jun 2004, 01:52 PM EDT
Msg. 158735 of 158790
(This msg. is a reply to 158732 by fenderbender60.)
Jump to msg. #  
Was Hawkins forced out of last position...?
While SPARKR provided an interesting, upbeat post, did Hawkins explain why she was forced out of her last position?

A google of the news stories from that time clearly indicates that she was either forced out or stepped over by other candidates within the company.

Her positions took on less and less responsibility over time, with other people assuming the responsibilites she had.

I have nothing against her - all indications are that she is professional and sincere.

But, she was clearly forced out for some reason and, I suspect, took the ADVR job because it was the best she could get.

Overall, the key is for her to keep The Moron Wilner as far as humanly possible from the actual operations of ADVR, as he has done untold damage to the company.

The drug could be so much farther ahead now if not for him...