Tuesday, January 25, 2022 9:23:59 AM
Uddin also commented on a recent event from competitor Sesen Bio, which on August 13 received a complete response letter (CRL) from the US FDA on a BLA for its Vicineum in BCG- unresponse NMIBC. Uddin related that Sesen aims to meet with the FDA in the fourth quarter of this year to get better clarity on next steps. The analyst said the announcement could open a potential window of opportunity for TLT, saying,
“On August 18th, a report by STAT News, which was based on SESN’s internal documents obtained by STAT, stated SESN’s pivotal trial with Vicineum had thousands of violations of study rules, investigator misconduct and worrying signs of toxicity SESN did not publicly disclose,” Uddin wrote.
SESNSept 1 2021 Research Capital Uddin TLTFF
JMO, maybe, maybe not.
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