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Chemdeps

12/03/16 6:32 AM

#81809 RE: blu_1 #81808

Which is why a lot of small biotechs partner after Phase II or are acquired by BP at that time. If Phase II results prove to be as strong as the early hints and indications, Missling can decide to seek funding and pursue Phase III alone or he can elect one of many potential partners that will be tripping over themselves to support the phase III. If there are other indications like Retts or Parkinsons, the price tag could be substantial.
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kld2

12/03/16 7:35 AM

#81810 RE: blu_1 #81808

voice of reason. Thanks.
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2014turnaround

12/03/16 8:47 AM

#81821 RE: blu_1 #81808

What happen to the nothing works scenario,Gild's HIV drug sure was quick to market,I would think alzheimers is just as important as HIV!
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XenaLives

12/03/16 9:39 AM

#81831 RE: blu_1 #81808

Yep, you're talking apples and oranges.



Ph 3 trials take about 4 years to complete. That's abut how long Biogen's is estimated to take. They're enrolling 2700 patients however.



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XenaLives

12/03/16 9:49 AM

#81833 RE: blu_1 #81808

Apparently the FDA disagrees with you:


The placebo-controlled trials that the Agency relies on to support a finding of substantial evidence of effectiveness vary considerably in duration. Treatments designed to treat acute migraine headache typically study only a single headache (because subsequent headaches are intermittent and considered independent events that are expected to respond equally to treatment), while treatments for various forms of multiple sclerosis may have controlled portions of up to 2 years. As a general principle, studies of treatments for chronic conditions should (and do) assess drug effect for at least 3–6 months in a controlled setting, but the duration may need to be longer if the number of events necessary to be able to detect a drug-placebo difference are relatively rare (for example, studies of relapsing-remitting multiple sclerosis (MS) may need to be 1–2 years long in order for enough relapses to occur to be able to detect a between-treatment difference). Some studies of the acute phase of relatively chronic conditions [e.g., acute major depressive disorder (MDD), acute schizophrenia] are relatively brief (2–8 weeks), largely because patients cannot continue placebo treatment for very long (there are too many discontinuations after this duration to be able to adequately analyze the trial). In all instances in which prolonged treatment with placebo is untenable or clinically questionable, protocols contain contingencies to “rescue” patients with effective treatments.







https://www.ncbi.nlm.nih.gov/pmc/articles/PMC534930/