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FDA Grants Hoth Pre-IND Meeting On Proposed Drug Development Plan For HT-001 Treatment

Hoth Therapeutics Inc. (HOTH) said that the Pre-IND meeting requested last month for HT-001 with the U.S. Food and Drug Administration Division of Dermatology and Dental Products has been granted to receive written responses only from FDA that are targeted for delivery on February 22, 2021.

In Wednesday pre-market trade, HOTH was trading at $2.40, up $0.16 or 7.14%.

The Pre-IND meeting topics include the acceptability of the overall proposed drug development program for HT-001 including requirements for nonclinical, clinical pharmacology, clinical, chemistry, and manufacturing controls.

The company noted that the proposed clinical trial designs for the first clinical studies (phase 2) in the HT-001 program are also included in the Pre-IND meeting topics to receive FDA feedback.

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