And Phase 3, Consolidation, and Phase 4, Boom II, are waiting in the wings.
The other drug in Phase 3 trials is Viread--Gilead's biggest-selling drug to treat HIV.
Its most advanced product, in Phase 3 clinical trials, aims at preventing chemotherapy-induced nausea and vomiting.
Eliminating phase 3 studies would erode the attempts that the industry is making to restore its image.
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In 2010, Lilly halted phase 3 development of semagacestat after it was found to actually worsen Alzheimer's.
The expenses of phase 2b and phase 3 trials can often crowd out work on early programs.
However, the cost of the phase 3 program is on the order of a half a billion dollars.
Sometimes, the best thing to do is to bite the bullet and plunge into the phase 3 program.
Given the phase 3 outcome, the naysayers felt that their concerns were validated.
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However, the numbers in the phase 3 studies ran in the wrong direction.
United Therapeutics Corporation ( UTHR) said today its Phase 3 trial of oral treprostinil, did not meet its primary endpoint.
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But Bristol-Myers said the data are strong enough to move to larger phase 3 trials, expected to launch by year's end.
However, this is the THIRD CETP inhibitor to advance to phase 3 with the Pfizer and Roche entries having failed previously.
Finally, any phase 3 program involving thousands of patients is always risky in terms of not just efficacy but also safety.
Today Biogen Idec (BIIB) reported top-line results of EMPOWER, a Phase 3 trial investigating dexpramipexole in people with amyotrophic lateral sclerosis (ALS).
The investment the company makes in committing to phase 3 is considerable.
But phase 3 trials are crucially important for a number of reasons.
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Primary end-points are needed for definitive (Phase 3) proof of efficacy, but they are the most pernicious concept in early stage development.
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The stock continued its climb as news of the tivozanib trial results from Phase 2 and the rapid enrollment in Phase 3 occurred.
An obesity drug, similar to Accomplia from Sanofi-Aventis (nyse: SNY - news - people ), also just entered Phase 3 trials.
The reason for this criticism was that the mid-stage clinical trials with bapi gave equivocal results and plunging into phase 3 was highly risky.
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One concrete development to watch for in 2008 is how the TroVax vaccine, made by Oxford Biomedica, performs in its Phase 3 clinical trials.
Gilead's two drugs in Phase 3 trials--the ones most likely to be approved next--are extensions of Gilead drugs that are already approved and marketed.
To answer these questions, the phase 3 program will be longer to determine if the new cancer drug has any survival advantages over Xalkori.
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We have entered Phase 3 of the post-Jobsian era, when Apple begins to be perceived as just another company rather than some superhuman entity.
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However, once a drug is approved in a case like this, the situation changes drastically for the next such drug that advances to phase 3.
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However, such opportunities also can evolve into costly phase 3 programs.
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With financial backing from Glaxo Smith Kline, Synta went to a Phase 3 trial of the drug on six hundred and fifty-one patients in late 2007.
Also today, Trius Therapeutics (TSRX) said a phase 3 trial of its tedizolid phosphate treatment for bacterial skin and skin structure infections met its primary endpoint.
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