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keltoi

10/04/10 5:07 PM

#38909 RE: KuChing #38850

If I may , let me "kill a few birds with one stone".It is now 4:30PM Monday.I just got home and logged on.The afternoon NNVC "soap opra" was a heated one.
The whole afternoon , in my opinion , was totally wasted.Dr.Feelgood was doing his best debating someone who has a "one track mind" and is "beating a dead horse" regarding mice.
I've learned long ago that if someone does not add Value to your life (education , confidence , support etc.),pass them by.You can't argue with people who just argue all the time.
Dr.Harris is the preeminent researcher that the FDA relies on regarding virology , especially Dengue.If she wants to use earthworms for her research and has good reason for doing so , she has the credentials to back it up.Earthworms , chickens , orangutans , mice , zebras , penguins etc.It doesn't matter to me if she has a valid use for them and can back it up.
The one arguing with Dr.Feelgood is in the wrong forum.He/she should be arguing in the Journal of Viruology and with Dr.Harris.If He/she can win that debate then I'll listen to them.No P.H.D.? Don't bother me "here's a quarter", call someone who cares.
My next post will answer your question as I went long on this one.
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keltoi

10/04/10 5:31 PM

#38914 RE: KuChing #38850

The FDA has a network of respected researchers that they rely on.Dr.Harris is one of them (in the case of virus infections , especially Dengue).It normally takes at least 18 months to "worm your way"through the FDA for drug approval.
My research and sources inform me that a PRV with the FDA will "shortcut" the process to possibly 6 months.
Dr.Harris didn't just sign a testing agreement with NNVC , she signed an R&D agreement with them.
The tests done in June were a resounding success resulting in survival of 50% of the doomed mice with no toxicity reported.That has never happened before.(She , BTW , designed the mouse model to be used).
In this "quiet" period since,she is now working with NNVC to tweek and bring the therapy(Notice I'm not using the terms vaccine or drug)to as close to 100% efficacy as possible.
Her journal article could take 6-12 months before it appears and the journalists jump on it and the stock is off to the races.
In the meantime when the tweeking is done her approval clears the way for the FDA to grant a PRV which could easily occur before the journal publishing.The FDA doesn't have to wait for a journal article and also Dr.Harris , being the humanitarian that she is would certainly want to assist in saving lives with this therapy as quickly as possible.