SESEN BIO Forum: Community User: fb19077

Die Frage ist jetzt bleibt es beim 12.11. für weitere infos oder schieben die das auf Dezember weil da ja auch ein Regulatory Update kommen soll.

Sehr gute Neuigkeiten 👍

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 5, 2019-- Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today reported alignment with the FDA on the design of its post-marketing confirmatory trial for Vicinium. Sesen Bio reached agreement with the FDA that the post-marketing confirmatory trial for Vicinium will enroll BCG-refractory patients who have received less-than-adequate BCG*, which is especially important in light of the ongoing BCG shortage. This represents a broader patient population than the originally proposed BCG-intolerant population. It is anticipated that, if Vicinium is approved by the FDA, the initial indication will be for BCG-unresponsive patients who have received adequate BCG. However, assuming the post-marketing confirmatory trial is successful, it is expected that labeling will be expanded to include this additional population of patients who have received less-than-adequate BCG. “This was our third face-to-face meeting with the FDA in the past 6 months, and we continue to have very positive and constructive interactions, which help us advance Vicinium toward regulatory review and approval,” said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. “Our long-term relationship with the Agency has allowed us to shape our clinical program in alignment with FDA guidance. It has also helped to ensure that we are able to address the broadest possible segment of appropriate patients, and is expected to provide payers with the superiority data that will help to ensure product reimbursement. We look forward to our next FDA meeting in December.” The trial is expected to be powered to demonstrate the superior efficacy of Vicinium compared to currently utilized therapies for the primary endpoints, which are expected to include the complete response (CR) rate and duration of response in CIS patients. Secondary endpoints are expected to include a number of quality of life, survival and safety endpoints, with the objective of demonstrating the superiority of Vicinium relative to currently utilized therapies. In addition, after a discussion of favorable Phase 3 post-hoc analyses with the FDA, the trial is expected to be designed to detect a delayed CR in patients who were non-CRs at the initial 3-month assessment. Key Fourth Quarter 2019 Events FDA meeting on December 4, 2019 to discuss the submission strategy for CMC Module 3 Anticipated initiation of BLA submission under a Rolling Review in December 2019 Sesen Bio Regulatory Update in December 2019 * As per the 2018 FDA guidance on NMIBC, adequate BCG is defined as at least 5 doses in an initial induction course, plus at least 2 doses in a second course.

Geschaft

Das sind wir morgen schon

Schwach ist das sie sich erst am 12. äußern wollen,bis dahin können wir unter dem $ sein...

Die Frage ist, wie Hoch ist der neue Preis für die Ausübung der Optionsscheine!!!

Das Risiko von Penny's.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 29, 2019-- Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today reported modifications to its 2017 and 2018 common stock warrants, which enhance the Company’s capital raising optionality by allowing for future at-the-market (ATM) programs. “Today we took an important step to enhance our capital structure, giving us the tools to potentially build upon our financial position with a number of upcoming value-inflection points over the next year,” said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. “This was an important strategic decision to position the Company with the greatest optionality as we prepare for upcoming FDA engagements, our planned BLA submission and a potential future approval of Vicinium for patients with non-muscle invasive bladder cancer. The remainder of 2019 will be a critical period for Sesen Bio, and we look forward to continued progress across the organization.” Key Fourth Quarter 2019 Events FDA meeting on November 4, 2019 to discuss the post-marketing confirmatory trial for Vicinium FDA meeting on December 4, 2019 to discuss the submission strategy for CMC Module 3 Anticipated initiation of BLA submission under a Rolling Review in December 2019 The Company will provide more information at a Business Update on November 12, 2019 at 8:00 a.m. EST. To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 1377227. The webcast can be accessed in the Investor Relations section of the Company’s website at www.sesenbio.com. The replay of the webcast will be available in the Investor Relations section of the Company’s website at www.sesenbio.com for 60 days following the call.

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