A hedgefund trolls life is so transparent and pathetic... and they are a little cranky since they are not making any money these days. lol
A transcript of the NIH plan/presentation can be found on phoenix rising forums, here:
Transcript of Dr. Vicky Whittemore's ME/CFS proposal to the NIH Council, 26 May 2016
Ah yes, I remember that of course, but that wasn't Cort, that was a Julie Rehmeyer interview.
It looks like the working group has now devised their strategy,
I watched it. Very brief, no details. This is a preliminary to RFA proposals.
Where did you read Cort said there were rumors of amp and ritux funding in the proposal?
Another take - which includes clinical trials.
Yes, not a lot of details presented. Whittemore proposed a consortium of research centers, most likely at universities, to collect a cohort of ME/CFS patients and carry out various studies, including clinical trials. She mentioned young investigator training, too, which is important. So the proposal is to build out a network of centers equipped to do long-term research. The council approved the proposal. Now, I believe, all of the 24 institutes involved in the Trans-NIH Working Group on ME/CFS have to kick in funding. At least that's what I think the next step is.
Edit: One council member asked about patient input, and Whittemore said that patient involvement would be baked into the research centers.
Bob Millers report:
Today Vicky Whittemore presented the #MECFS Working Group’s proposal to fund a multi centered research consortium
during the open session of the National Advisory
Neurological Disorders and Stroke Council. The proposal was voted on and unanimously approved. Dr. Walter Koroshetz of #NINDS was in attendance and supported the proposal. To view the meeting go Here: videocast.nih.gov
The recording will also be archived and
available for future viewing.
Right. Otherwise they would not be talking to heb. I'm optimistic, no one else has does a pivotal phase iii trial for cfs. A biomarker or discovering the cause would help. NIH is finally, after 30yrs, beginning to take the disease seriously.
Well, there were no details - this was obviously a done deal before Whittemore made her brief presentation - but they did not talk about clinical drug trials, so it may be research trials, or a combo - we'll have to wait for details.
And it seems a bit of wheel spinning, Koglenick has a consortium already, HEB has a consortium of trial sites as well. so we'll have to wait for details I think.
Here is a summary:
Fund a consortium with several sites, plus a data management center. Ability to add additional consortia or sites.
NIH planning for clinical trials across the consortia.
Current researchers mostly in private practice.
Similar to rare disease structure. Patients and advocates are included in that. Patient engagement to be large part of consortium.
The NIH me/cfs plan is approved unanimously.
I wouldn't be bothered by it JJ, the hedgies don't have much else to post about and this stuff does not bother me one iota - otherwise I would have stopped posting long ago. lol
I agree, heb management is doing their best to put on the pressure... speaking of which...
The timing is also interesting in that yesterday was the millionsmissing global day of protest for CFS/ME. Hugely successful. Major cities all over the world. Ron Davis spoke in San Francisco - a huge help to have a world class scientist protesting - saying they are very close to a biomarker. To check it out enter in twitter the hash tags of millionsmissing and/or meaction.
Also, NIH to announce major research funding today 2pm eastern
Today: Videocast of NIH Council Meeting to authorise major ME/CFS funding - Thursday 26 May 2pm EDT
Times, they are a changing...
I didn't find that reference in the paper - but I agree that the FDA has most likely agreed to wave the rat study. From 2013:
The rodent data was simply irrelevant ; unlike humans rodents were slow metabolizers of the drug – which meant the drug sat around in their systems for long periods of time – a danger not faced by humans. Only primates, Dr. Carter asserted, were acceptable test animals for this drug.
The full text of this supplementary information is now online.
Efficacy of rintatolimod in the treatment of chronic fatigue
syndrome/myalgic encephalomyelitis (CFS/ME)
by William M Mitchell
I like your take. 2015 was an incredible year of progress for CFS, the pressure on the gov't will only increase. In fact there is a rumor of a big paper to be published soon. The kind you can beat HHS over the head with.
Yup, my thought too. ...which the fda should have dropped long ago - but regardless, a good sign, I like it.
"and FDA officials have said that the safety issues for the drug have been resolved."
Hey JJ, that's a curious statement by the FDA. I've got a guess at what safety issue or "gap" has been resolved. Any guesses?, ...in this new era of reconciliation...
May 2, 2016
"The FDA, however, acknowledges that ME/CFS community urgently needs drug options, and FDA officials have said that the safety issues for the drug have been resolved. Some advocates that have met with them believe they are eager to move forward on ME/CFS.
Equels said he’d met with Janet Woodcock at the FDA to understand where the FDA sees the gaps. He pledged Hemispherx would be there “arms locked with FDA officials” to do what was necessary to move the drug forward. Hemispherx officials also apparently quickly talked with NINDS chief Dr. Koroshetz not long after NIH Director Collins announced the NIH would reinvigorate ME/CFS research.
At the end of the day, Equels said, we have a proven therapy – it’s about bringing it across the finish line."
Clinical trials to secure medical treatments for ME/CFS
We demand the NIH immediately partner with the FDA to address the key obstacles to moving clinical trials forward. NIH must also actively incentivize pharmaceutical and biotech industries so that at least five accelerated clinical trials of medications are conducted over the next five years. The goal must be getting at least two FDA-approved medications on the market for ME/CFS patients in the next five years. Proposed medications include Ampligen,[iv] Rituxan[v] and antiviral medications,[vi] all drugs that have been in trials already and have been successfully used to treat ME/CFS patients.