Friday, December 08, 2017 4:37:35 PM
"The discussion focused on elements of proposed clinical trial designs, both single-arm and controlled, which the FDA agreed would be appropriate to support a registrational trial of HS-110. Clinical endpoints and post-marketing commitments were also discussed in the context of ACCELERATED APPROVAL."
ACCELERATED APPROVAL was discussed! This is not bad news! It is good news for the company, and for potential partners. I would like to know more! The current trial is open label...so accelerated approval could come well before Heat has the full phase II trial results... accelerated approval opens many potential possibilities. We'll see more news comes out next.
"The refusal of the real is the number one dogma of our time" Rene Girard
Recent NHWK News
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 08/07/2024 04:15:18 AM
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- Form 8-K - Current report • Edgar (US Regulatory) • 04/30/2024 12:00:10 PM
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- Form 8-K - Current report • Edgar (US Regulatory) • 04/22/2024 09:00:14 PM
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