Antibe Therapeutics Inc(Pre-Merger) ATBPF

Healthcare

Antibe Therapeutics Inc. is a clinical-stage biotechnology company. The Company is leveraging its hydrogen sulfide (H2S) platform to develop therapies to target inflammation arising from a range of medical conditions. The Company’s pipeline includes assets that seek to overcome the gastrointestinal ulcers and bleeding associated with nonsteroidal anti-inflammatory drugs (NSAIDs). Its lead drug, otenaproxesul, is in clinical development as an alternative to opioids and NSAIDs for acute pain. Its second pipeline drug, ATB-352, is being developed for a specialized pain indication. The Company also focuses on inflammatory bowel disease (IBD). Otenaproxesul combines a moiety that releases hydrogen sulfide with naproxen, a non-steroidal, anti-inflammatory drug. ATB-352 is an H2S-releasing derivative of ketoprofen, a potent NSAID commonly prescribed for acute pain. Its IBD candidates are being designed to maintain the efficacy, safety, and pharmacokinetic properties of ATB-429.

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Comment by TriumphSpitSixon Jan 27, 2021 2:32pm

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Post# 32400958

RE:RE:RE:More Dumping

"The European Medicines Agency (EMA) maintains a list of class waivers for medicines that are not required to submit a paediatric investigation plan (PIP) as part of a marketing authorisation application. These medicines are likely unsafe or ineffective in children, lack benefit for children or are for diseases and conditions that only affect the adult population."

https://www.ema.europa.eu/en/human-regulatory/research-development/paediatric-medicines/paediatric-investigation-plans/class-waiversThe European Medicines Agency (EMA) maintains a list of class waivers for medicines that are not required to submit a paediatric investigation plan (PIP) as part of a marketing authorisation application. These medicines are likely unsafe or ineffective in children, lack benefit for children or are for diseases and conditions that only affect the adult population.

*with very few exceptions due to rare one-off diseases that do not affect the vast bulk of the population.

saxy4uhere wrote: is it part of registration? An exemption from the obligation to submit a paediatric investigation plan for a class of medicines, such as medicines for diseases that only affect adults. Class waivers are adopted by the Paediatric Committee (PDCO).

Class waiver | European Medicines Agency