OPEXA WKN: A2DYQV ISIN: US00444P1084 Kürzel: P6NA Forum: Aktien Thema: Hauptdiskussion

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Acer Therapeutics: Undervalued With A Free Call Option On EDSIVO https://seekingalpha.com/article/4289799-acer-therapeutics-undervalued-free-call-option-edsivo?source=quotemedia_readmore

Second Quarter 2019 and Recent Events ACER-001 Investigational New Drug (IND) application cleared for initiation of pivotal bioequivalence bridging and taste assessment trials of ACER-001 compared to sodium phenylbutyrate Disclosed osanetant clinical development plan for patients with induced Vasomotor Symptoms (iVMS), which may include patients receiving tamoxifen treatment for breast cancer and/or leuprolide treatment for prostate cancer and/or women who elect to have prophylactic bilateral oophorectomy (surgical removal of ovaries) where Hormone Replacement Therapy (HRT) is likely contraindicated Ended the second quarter with $23.5 million in cash and cash equivalents, which the Company believes will be sufficient to fund its current operating and capital requirements through the end of 2020 Upcoming Milestones EDSIVO™ Conduct Type A meeting with FDA in Q3 2019 to discuss EDSIVO™ Complete Response Letter ACER-001: Conduct Type C meeting with FDA in 2H 2019 to discuss ACER-001 development plans Initiate ACER-001 pivotal bioequivalence bridging and taste assessment trials in Q4 2019 Submit ACER-001 New Drug Application (NDA) for UCD patients in mid-2020, assuming successful outcomes in bridging trials and sufficient drug product stability data to enable NDA filing Osanetant: Submit osanetant IND in Q4 2019 Initiate Phase 1/2 trial in mid-2020 evaluating osanetant in patients with iVMS, which may include patients receiving tamoxifen treatment for breast cancer and/or leuprolide treatment for prostate cancer and/or women who elect to have prophylactic bilateral oophorectomy (surgical removal of ovaries) where Hormone Replacement Therapy (HRT) is likely contraindicated  http://app.quotemedia.com/quotetools/newsItem.htm?webmasterId=102683&storyId=5960703527122220

Mal sehen wie die Amis es aufnehmen: Acer Therapeutics Receives Complete Response Letter from U.S. FDA for use of EDSIVO™ (celiprolol) in vEDS Patients    June 25, 2019 08:30 ET | Source: Acer Therapeutics Inc. NEWTON, Mass., June 25, 2019 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for EDSIVO™ for the treatment of vascular Ehlers-Danlos syndrome (vEDS). The CRL states that it will be necessary to conduct an adequate and well-controlled trial to determine whether celiprolol reduces the risk of clinical events in patients with vEDS. Acer plans to request a meeting to discuss the FDA’s response. “We remain committed to working closely with the FDA to fully understand its response,” said Chris Schelling, CEO and Founder of Acer. “We expect to respond to the FDA in the third quarter of this year.” https://www.globenewswire.com/news-release/2019/06/25/1873784/0/en/Acer-Therapeutics-Receives-Complete-Response-Letter-from-U-S-FDA-for-use-of-EDSIVO-celiprolol-in-vEDS-Patients.html

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Sonst noch jemand investiert oder alle schon raus?

www.benzinga.com/content/9680711/acer-therapeutics-and-opexa-therapeutics-sign-merger-agreement

Bin gestern kurzfristig zu 0,93 € rein und schaue mir die Woche mal an was nach der Merger Nachricht noch passiert.

Bin jetzt auch zu 1,11€ drin. Hoffe das war kein Fehler und wir sehen die 4€ bald

Zu welchem Kurs??

War ja vor kurzem noch über 4€, ich les mich mal hier etwas ein, bin schon interessiert,-)

Geht ja gut ab

Jemand investiert???