Prana Biotechnology Ltd. Message Board
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You make some excellent points. I'm just surprised that an MD doesn't "no" how to spell know.
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Another open with the bid up on a nice sized chunk (350k).
Click, click, click goes the reel. -
I keep thinking of that seen in Jaws where the reel on the fishing rod is starting to click really slowly, waiting for the shark to take the line.
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500k in the first 15 min and up .01
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The action was interesting this week. It makes me wonder if some news might be coming next week.
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Any ideas as to the nice price & volume trading characteristics?
by frobinso1 •May 15, 2013 9:42 AMThe real question is "How will it close?"
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Any ideas as to the nice price & volume trading characteristics?
by frobinso1 •May 15, 2013 9:42 AMBut why not get excited so we can have a thread speculating on why we're speculating.
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I sure hope the study designers know more than us investors or we're in real trouble! :-)
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Just a couple of points: 1) patients were allowed to be on tetrabenezine if they'd been on a stable dose for 6 months, 2) Prana may HOPE to not need a Ph3 given the new FDA guidelines but they didn't plan for that 2 year ago when they were designing the study,
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I think what they're really looking for in the 6 months is gain in executive function like what was seen in the 12 week PIIa prior study. If they meet safety (pretty much a given at this point) and get executive function gain, I think this will be considered a big success.
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Post Reach2HD results is nice timing.
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I'm sure Prana will release more news as to why they are different from the others. In the end, it will be the results that actually speak to the investment community.
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Aye, she's a fine lass!
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Who cares? They will have no earnings.
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Somebody just bought 2 shares on ASX. Who makes a transaction for $0.42?!?!
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Zavoico explains. The implication is that Prana might be able to expand its phase 2b into a pivotal phase 3 study just by adding patients, and without major modifications to trial design, thereby steering clear of a larger and lengthier phase 3 study measuring both cognitive and functional endpoints. This would diminish the burden immensely. "It means," Zavoico says, "that if this and a pivotal trial deliver positive results, then regulatory approval of PBT2 for the treatment of early AD could come as much as two or three years sooner than projected."
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Back in late December 2012, Zavoico said Prana Biotechnology Ltd. (PBT:ASX) represented one of the biggest risk/reward opportunities of this year with its investigational drug PBT2, which has restored cognition in mouse models of Alzheimer's disease (AD). PBT2 is currently in a phase 2b trial for AD and in phase 2a for Huntington's disease. The stock is up about 1% as of April 22 but has been volatile, due in part to its micro-cap status, with a $66M market valuation.
But does Zavoico's original thesis hold? "Perhaps even more now than before," he says. Zavoico is excited about the FDA's new draft guidance to the industry for developing drugs to treat early-stage Alzheimer's. "That was recognized as being a potential game-changer—when two FDA physicians, Nicholas Kozauer and Russell Katz, wrote a "Perspective" piece on how the FDA is considering changes to its criteria for approving drugs for early AD," he says. The piece was published online in the New England Journal of Medicine in March.
"They wrote that innovative approaches to trial design and endpoint selection are 'urgently needed.' The take-away message is that they would like to see the FDA approve drugs shown to have a beneficial effect on cognitive function alone, since there may not be any overt symptoms of functional deficits in early stages of the disease, especially before dementia. They are also supportive of biomarkers of disease, such as brain-amyloid load and cerebrospinal fluid levels of beta-amyloid and tau proteins," says Zavoico.
"It remains to be seen whether the FDA adopts the proposals in its draft guidance as written. The public comment period is over now, so we expect the next iteration of the guidance to appear soon. What is relevant to Prana is that the design and endpoints of its ongoing phase 2b trial in Alzheimer's may already be what the FDA will consider approvable," Zavoico explains. The implication is that Prana might be able to expand its phase 2b into a pivotal phase 3 stud -
That's an "old" joke.
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Interesting they are requesting before they've done a Phase II.
From a press release:
SEATTLE, May 1, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that it has requested Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the development of OMS824 for the treatment of Huntington's disease. OMS824 selectively inhibits phosphodiesterase 10 (PDE10), an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including Huntington's disease and schizophrenia. OMS824 has shown promising results in animal models directly relevant to Huntington's disease and, as previously announced, OMS824 was well tolerated and exhibited favorable pharmacokinetic properties in a Phase 1 clinical program. Omeros is currently advancing OMS824 into a Phase 2 program. -
Omeros Requests Fast Track Designation for OMS824 for the Treatment of Huntington's Disease
-- Phase 2 Clinical Trial Slated to Begin This Year --
SEATTLE, May 1, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that it has requested Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the development of OMS824 for the treatment of Huntington's disease. OMS824 selectively inhibits phosphodiesterase 10 (PDE10), an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including Huntington's disease and schizophrenia. OMS824 has shown promising results in animal models directly relevant to Huntington's disease and, as previously announced, OMS824 was well tolerated and exhibited favorable pharmacokinetic properties in a Phase 1 clinical program. Omeros is currently advancing OMS824 into a Phase 2 program.
FDA's Fast Track program facilitates the development of drugs intended to treat serious or life-threatening conditions and that have the potential to address unmet medical needs. Fast Track drugs are eligible for more frequent and timely meetings with FDA to discuss the development plan and to ensure that data needed for approval are collected appropriately. Drugs in the Fast Track program typically are granted priority review status and their respective New Drug Applications are accepted and reviewed by the FDA as rolling submissions.
"Huntington's disease is devastating, and there is agreement among specialists and affected families that the cognitive and behavioral symptoms of the disease are the primary source of functional impairment," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "There currently are no drugs that improve cognition in Huntington's patients nor are there any disease-modifying therapies. OMS824 holds the potential to improve both cognition and movement and to reduce the rate of neurodegeneration, thereby slowing disease p