Don you had stated "I'm hoping that an SPA and Phase 3 trial approval for AP534 will be forthcoming"
Although going from a Phase 1 safety study with about 80 patients to a full blown phase 3 is not unprecedented, I find it hard to believe that Aria would have the political clout to persuade the FDA to go directly to a phase 3 pivotal. If it were to happen it would have to be a huge trial and how long would it take to recruit probably 800+ patients ?
Of course this is only my opinion and I really hope you are right !
From the Clinicaltrials.gov website:
What are the phases of clinical trials?
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
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