Monday, December 24, 2012 1:33:30 PM
Folks just don't know what to think they read the message boards
and see partial truths and outright lies. The only way to be
successful with this is to take time to read the studies.
The panel information and the science behind this.
It is a unique array that is why the FDA is wanting to make
darn sure it was safe. We saw the vote.. It is looking good
on that. Now they want to see if it is effective.
Some say it is some say it is not. The Panel wants more info..
The info is there.. I just was not given to them in a way that pleases them .. . So this goes into the pizzing match phase.
Which is ok. The panel and the FDA really understand that
people are taking their lives because of this CFS. And that alone
with the safety vote, is enough to raise some serious concerns
on how to proceed imho. If the FDA shoots this down, I doubt
HEB will continue to even mess with it. You could hear the frustration from the HEB rep at the end of the meeting.
The panel is worried about a decreased white blood count
and a single monkey that had a blood clot. And HEB is concerned
about people who will have no hope for a cure. who just might
take their own lives due to political paperwork issues.
FDA has a really big opportunity to help people with CFS.
they can not ignore the 30 some odd public comments from those
who spoke to the panel, Some with some serious pedigree attached to their names. This is well worth the time and effort from both HEB and the FDA. Do I sing all good things for HEB and their methods. NOPE nada not a bit... They needed to have their collective tails chewed for the way they presented their findings.
Any high school kid in science class has at least a understanding of the Scientific Method. The step by step proving of a theory. Why were some of the steps not taken or changed without documentation. That lands right on HEBs doorstep and good for the panel for making it an issue. But the panel wants to move forward and so does the FDA and so does HEB as proven with the link of the continued study and trials.. That were not spoken of.
time will tell .. I hold out a pretty good glimmer of hope for those people with CFS and I think the FDA does also.
Pilot
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