Bullboard - Stock Discussion Forum Antibe Therapeutics Inc(Pre-Merger) ATBPF

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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,... see more

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Antibe Therapeutics Inc(Pre-Merger) > One step closer

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Post by RunningofdBulls on Jan 31, 2021 7:54am

One step closer

Fyi, excerpt below is from the recent EMA conference agenda held Jan 26-29, 2021, see page 41 and which can be found here: https://www.ema.europa.eu/en/human-regulatory/research-development/paediatric-medicines/paediatric-investigation-plans/class-waivers

6. Discussion on the applicability of class waivers
Disclosure of some information related to this section cannot be released at the present time as it is deemed to contain commercially confidential information.
6.1. Discussions on the applicability of class waiver for products 6.1.1. Paclitaxel - EMEA-12-2020 Athenex Inc.; First-generation taxoid medicinal products / Breast malignant neoplasms Action: For adoption
6.1.2. Otenaproxesul - EMEA-09-2020 Antibe Therapeutics; All classes of medicinal products for treatment of primary and secondary osteoarthrosis / Treatment of the signs and symptoms of osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers Action: For adoption

Class waivers are for medicines that are not required to submit a paediatric investigation plan as part of a marketing authorisation application.

I'm suspecting they got the waiver since last time I checked, children don't get OA!

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Comment by RunningofdBulls on Jan 31, 2021 7:58am

I posted the wrong link - here is the correct link to the agenda: https://www.ema.europa.eu/en/documents/agenda/agenda-pdco-agenda-26-29-january-2021-meeting_en.pdf

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Comment by Doccole on Jan 31, 2021 10:06am

What's next?

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Comment by MrMugsy on Jan 31, 2021 1:04pm

We are in the middle of partnering discussions and anything could eventually be announced here.I'm thinking something small will be announced to get some excitement going. No basis for this comment - just a feeling. While we are waiting for that to happen, I take my lead from BioPUB and the wording in Dan's comments. It seems the value driver continues to be academic work combined ...more

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Antibe Therapeutics Inc(Pre-Merger)