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Frank Reynolds - Invivo 4/29/13 video
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Originally posted by stephen212 View Post
We can all hope that the scaffolding does indeed prevent further damage. The real issues will be how many hours post contusion damage continues and how many get the device in a short window. So far nobody knows what the window of time truly is whether for this or cell interventions.
I have to be honest and say that I do not have the expertise to evaluate the cell actions that occur but remain skeptical until enough evidence presents for positive beliefs. If this does not work his stock will tank.
Late this year, the FDA approved the Humanitarian Use Device (HUD) route of InVivo's marketing permission application, allowing the trial of polymer scaffold into human beings early next year. It's absolutely a good green-light path for InVivo because the HUD designation and a subsequent approved Humanitarian Device Exemption (HDE) would enable InVivo to commercialize the devices in the U.S. faster than the regular Pre-Market (PMA) approval process. Moreover, the FDA committee also reduced the required number of human being to be tested from 10 to 5.
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Originally posted by lynnifer View PostWhy do you feel that way Majed? Honest question ... I'm not convinced.
results as misleading, but I don't think people like Bob Langer,
Richard Roberts and Reggie Edgerton would risk their reputations
on bogus results. They have an accomplished team, promising
results, plenty of ambition, and they have the ability to raise tens
of millions of dollars.
And I don't think they're less convincing than aynone else.
I agree with Wise Young that more clinical trials, trying many
different treatments is the key to success.
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Originally posted by Chaz19 View PostHey c473s, did geron seek the HUD?
Geron NEVER really intended to cure SCI, so they didn't care about HUD/ORPHAN drug status.
For geron SCI was just the fastest and cheapest way to prove safety of embrionic stem cells products to then move to more profittable deseases.
Unfortunatly very few people understands the real game so at the end of the day we keep supporting the ones that in fact f...k us.
PaoloIn God we trust; all others bring data. - Edwards Deming
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Originally posted by Buck503 View PostIt all comes down to judge of character. Some dismiss their animal
results as misleading, but I don't think people like Bob Langer,
Richard Roberts and Reggie Edgerton would risk their reputations
on bogus results. They have an accomplished team, promising
results, plenty of ambition, and they have the ability to raise tens
of millions of dollars.
And I don't think they're less convincing than aynone else.
I agree with Wise Young that more clinical trials, trying many
different treatments is the key to success."I'm manic as hell-
But I'm goin' strong-
Left my meds on the sink again-
My head will be racing by lunchtime"
<----Scott Weiland---->
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Originally posted by Chaz19 View PostHey c473s, did geron seek the HUD?
I hope Hans Kirstead can find somebody to pick the trial back up but with every passing day those odds drop.
I feel Geron bailed early and went after lower hanging fruit with the cancer market or they like so many find that cancer draws money at a far better rate of funding. I really dislike that choices are driven by economic factors but that is life unless a government or a Bill Gates steps in to SCI with a heart for the chase. Miami has not had enough $ to chase at a faster pace nor have any of the other "cure" foundations. (CDRF, Stifel, Bedford.....)
So many possible trials to chase and so far such a limited source of funding.
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Originally posted by Buck503 View PostIt all comes down to judge of character. Some dismiss their animal
results as misleading, but I don't think people like Bob Langer,
Richard Roberts and Reggie Edgerton would risk their reputations
on bogus results. They have an accomplished team, promising
results, plenty of ambition, and they have the ability to raise tens
of millions of dollars.
And I don't think they're less convincing than aynone else.
I agree with Wise Young that more clinical trials, trying many
different treatments is the key to success.
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Originally posted by c473s View PostIs Ed Wirth still there ? I think I heard he departed but maybe just rumor mill.
Ed is gone. Lots of new staff on the roster that's been there less than a year.
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Originally posted by Chaz19 View PostHe's working on the chronic model.
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