TETRA BIO-PHARMA WKN: A2ASQ8 ISIN: CA88166Y1007 Kürzel: TBP Forum: Aktien Thema: Hauptdiskussion

... Having submitted the response within the allowable timeframe allows Tetra to maintain its anticipated launching of REDUVO in the second half of 2021."

OTTAWA, ON / ACCESSWIRE / April 14, 2021 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX:TBP)(OTCQB:TBPMF)(FRA:JAM1), a biopharmaceutical pioneer in immunomodulator drug discovery and development announce they have advanced the REDUVO soft gel capsules New Drug Submission (NDS) file by responding to a request for more information from Health Canada, as previously announced on March 15, 2021.

https://ceo.ca/@accesswire/fda-provides-positive-feedback-on-tetra-bio-pharmas-311f2

TBPMF : Health Canada gives green light to Tetra Bio's ARDS-003 trial in COVID-19 • 5:04 AM Tetra Bio-Pharma (OTCQB:TBPMF) announces that Health Canada supports the filing of a Clinical Trial Application (CTA) for assessing their novel drug candidate, ARDS-003, in patients with COVID-19. Tetra's trial will be the first worldwide drug which involves the use of an injectable sterile synthetic cannabinoid in patients infected by COVID-19. The proposed study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ascending doses of ARDS-003 in hospitalized COVID-19 patients with pneumonia and at risk of developing acute respiratory distress syndrome. Health Canada acknowledged that Tetra's extensive nonclinical data meet the authority's requirements for a New Molecular Entity and granted the Company the approval for filing a CTA. The authorities also agreed on the proposed study design, target population, and primary and secondary objectives and endpoints of the study in severe COVID-19 patients. The investigational drug is designed to dampen the cytokine release syndrome and will be administered in combination with dexamethasone

https://finance.yahoo.com/news/tetra-bio-pharma-initiates-additional-060000466.html

https://twitter.com/Drpower_2000/status/1372952405520875520?s=19

Short Intrest... https://twitter.com/Habilis15/status/1372973841551622148?s=19

Darauf erstmal 8% runter 😂 alles nicht normal...

Top. Danke Hanni👌

https://ir.tetrabiopharma.com/newsroom/press-releases/news-details/2021/Tetra-Bio-Pharma-Receives-Compliant-Rating-on-Inspection-from-Health-Canada/default.aspx

Dann hoffen wir mal auf die Pipeline, denn die eigentliche Meldung ist dünn: The dossier at Health Canada completed the screening phase. To facilitate the product approval, and due to the nature of the data supporting the NDS, Health Canada has recommended an unconventional regulatory pathway and therefore requested additional information to fulfill all requirements of that proposed prescription drug approval pathway. The positive feedback and communication received from Health Canada, which are part of the regular review process, do not increase the expected review timeline. Tetra is working towards submitting the response to Health Canada within the allowable timeframe.

Keine Sorge ich weiß schon was ich mache. Hab den Laden schon sehr lange auf dem Radar. Der liebe Jack pusht das jetzt (bezahlt) und das macht der nur, wenn einige Katalysatoren in der Pipeline sind.

Wenn man keine Zeit hat sollte man nicht in sowas investieren. Forschung + behördliche Genehmigungen brauchen nun mal mehrere Jahre / Jahrzehnte.

Hab keine paar Jährchen Zeit. Von 13Cent, ein paar 100% Plus, dann darf es sich Zeit lassen. Aber jetzt soll erst mal der WSR Jack ordentlich anschieben. Dafür wird er bezahlt und der soll jetzt mal liefern!

Das dauert noch ein paar Jährchen Hanni. Dann aber richtig.

Soll jetzt mal loslegen das Ding...