GETA LOOK AT THE HIDDEN AGENDA...FDA IS IN THE BAG
Have you ever read the Agenda Trial?
I've been data mining and let me show you what I found interesting.
All GETA has to do to get FDA Approval is to prove its is better then
this 35 year old drug.....Dacarbazine
It has already done that, hands down. GETA will replace Dacarbazine,
for the next 25 -30 years. Bottom line all Agenda has to do is **
( determine whether dacarbazine plus Genasense is significantly
better than dacarbazine plus) PERIOD
Read and compare the purpose of these trials Trial of Dacarbazine With
or Without Genasense in Advanced Melanoma
(AGENDA)
Purpose
This study is being performed to prospectively**( determine whether
dacarbazine plus Genasense is significantly better than dacarbazine
plus)**placebo in chemotherapy-naive patients with advanced melanoma
and low baseline LDH
(GM301)
Purpose
**(LDH less than or equal to 0.8 times the upper limit of normal).LDH
is a biomarker strongly associated with improved outcomes in a recent
trial of dacarbazine plus Genasense.
I believe Genasense will preform the best when its efficacy
parameters have been met LDH [⩽1.1×upper limit of normal (ULN)], The drug was used to early so it did not show a significance in and was used to
late to be effective last trial.
Bottom line all Agenda has to do is **( determine whether dacarbazine
plus Genasense is significantly better than dacarbazine plus) PERIOD
_____________________________________
AGENDA
**(LDH less than or equal to 0.8 times the upper limit of normal)
COMPARE VS <.8 significant?
<1.1
GM301
**(All efficacy parameters significantly favoured dacarbazine–
oblimersen in patients with normal baseline **LDH [⩽1.1×upper limit of
normal (ULN)]**
Timing is everything,
*****Dacarbazine generally produces poor outcomes. Adding other
therapies offers minimal clinical advantages. In general, [the
quality of dacarbazine studies] is poor and sample sizes are small.
This . . . highlights the unmet need for effective treatment options for
advanced melanoma.”*****
Cancer Chemotherapy for Melanoma: Dacarbazine
DTIC-Dome
FDA Approved****
1975****
Description
Dacarbazine is an "alkylating agent" that links together specific
sections of DNA, which then prevents cell division and results in
cell
death. It is similar to the chemotherapy drug temozolimide.
Usage of Dacarbazine
Injection into a vein
Evidence that Dacarbazine is Effective ?NOT
Dacarbazine is currently the only FDA-approved chemotherapy drug for
metastatic stage IV melanoma. While it is the best available
treatment and the standard against which new melanoma drugs are evaluated, it is unfortunately not very effective: a recent review of the research
showed an average response rate of only 15.3% with no significant
improvement in overall survival. Almost all responses were partial,
with a median response duration of only 7 to 8 months. Dacarbazine has
also been studied in combination with other drugs, as in the CVD
(cisplatin, vincristine and dacarbazine) and BVLD (bleomycin,
vincristine, lomustine and dacarbazine) combination regimens. The
evidence so far, however, does not show an advantage over the use of
dacarbazine alone.
Researcher Philip Lui, PharmD of Toronto General Hospital, concludes,
“
Hey what if Genasense didn't work ......... that well, its better
than the 35 year old standard. Its time for the standard to retire.
Peace ... GETA conspiracy theory or plausible ?
thinkfish
AI
