SPERO THERAP.INC. DL-,001 WKN: A2H63F ISIN: US84833T1034 Kürzel: 2HA Forum: Aktien Thema: Hauptdiskussion

Jetzt ist Geduld gefragt aber das wird sich auszahlen

Die nächsten Milestones wären m.E: die Veröffentlichung der Planung und des Starttermins von Phase-3 des Tebipenem-Projekts (hätte sich der eine oder andere vllt schon im Rahmen des Quartalsberichts erhofft) und dann der eigentliche Start der überarbeiteten Phase 3. Kann mir vorstellen, dass der eine oder andere Investor das Geld erst einmal in anderen Titeln parkt, in denen aktuell mehr Bewegung im Kurs ist.

warum geht die so in Keller?

Im Pre-Market sieht alles fein aus - um die 2$

Bin gespannt wie und ob die USA auf die Informationen reagiert.

Diese Facts sind meiner Meinung nach das, was zählt - nicht ob die Earnings leicht verfehlt oder übertroffen wurden

Ritu Baral Good afternoon, guys. Thanks for taking the question. I wanted to ask about the final Phase III that was agreed upon following the Type A meeting and the minutes. Can you guys talk about the major differences between the upcoming study on your prior study? Specifically how any patients, I think, with will be handled whether you have the full P value of 0.05 for this study? And if you'll be using the same sites? Thanks. Ankit Mahadevia Thanks, Ritu. I'll hand this question over to Kamal. Kamal Hamed Yes. Thank you for the question. So we're still in discussions about the final -- the design of the final Phase III. Of course, we have the Type A meeting with FDA and that provided clarity on the -- on how to approach the next Phase III study, but we are currently in discussions with our partner GSK. And the final protocol design will be disclosed after we've reached agreement with GSK. Ritu Baral Got it. But that's -- the trial is still on track to start in 2023. Is that correct? Kamal Hamed It is correct.

https://seekingalpha.com/article/4557793-spero-therapeutics-inc-spro-q3-2022-earnings-call-transcript

Looking ahead for tebipenem HBr, we expect to initiate a new Phase 3 clinical trial in 2023. Prior to entering our agreement with GSK, we aligned with the FDA on key components of the trial design at the recent Type A meeting. Feedback from this meeting indicated that positive results from this single additional trial together with confirmatory nonclinical evidence of efficacy could be sufficient to support tebipenem HBr's approval for the treatment of complicated urinary tract infections, including pyelonephritis for a limited use indication. This upcoming pivotal trial will build upon the extensive clinical and nonclinical data, previously generated with tebipenem HBr, which include the results of our prior Phase 3 clinical trial ADAPT-PO. The results of this clinical trial, which were published in the New England Journal of Medicine, demonstrated that oral tebipenem HBr was well tolerated and non-inferior to IV ertapenem in the treatment of adult patients with complicated urinary tract infections or acute pyelonephritis as per the pre-specified statistical protocol. We are currently working to finalize the design of our upcoming trial, which will be the subject of a special protocol assessment request. With a review of our newly forged partnership complete, I'd like to now introduce Spero's recently appointed Chief Medical Officer, Dr. Kamal Hamed. Kamal joined Spero in September, bringing with him an impressive range of experience within the biotech industry global pharmaceutical companies and as a practicing physician caring for patients with infectious diseases. He has a long track record in infectious disease drug development, including multiple drug approvals. He's integrated seamlessly into his new role at Spero and has displayed the expertise and commitment to our Spero values that made him the ideal candidate to serve as our CMO. With the added strength Kamal brings to our management team, our clinical pipeline and our GSK partnership, we've laid the foundation for sustained growth into 2023 and beyond. We have cash runway through key milestones for each of our clinical programs and have a deeply talented team in place.

Nachbörslich -7% ...Aber eigentlich sind die News doch Super?!

Warten wir es mal ab

Keine schlechten News, nur nicht so viel Neues. Aber mal schauen, was die Presse morgen schreibt, gab ja auch noch eine Live-Präsentation dazu.

Sind ja nicht so gute News oder

„initiation of a placebo-controlled Phase 2 trial designed to provide clinical proof-of-concept for SPR720 in nontuberculous mycobacterial pulmonary disease with top line results expected in 1H 2024“

„Prior to entering into the exclusive license agreement with GSK, Spero completed a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the regulatory pathway forward for potential approval of tebipenem HBr. During the meeting, the FDA indicated that positive results from a single additional Phase 3 clinical trial supported by confirmatory nonclinical evidence of efficacy could be sufficient to support the approval of tebipenem HBr for the treatment of cUTI, including pyelonephritis for a limited use indication. Spero and the FDA also achieved alignment on key components of the proposed pivotal Phase 3 trial design which will be the subject of a Special Protocol Assessment request, to be confirmed once the clinical protocol is finalized.“

https://s3.amazonaws.com/b2icontent.irpass.cc/2748/rl113755.pdf