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Biotech / Medical : Immunomedics (IMMU) - moderated -- Ignore unavailable to you. Want to Upgrade?

To: weatherproof who wrote (45935)4/28/2018 10:18:33 AM
From: Smoke Reader1 Recommendation

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  Read Replies (1) | Respond to of 58497
For what is worth, I am quoting from the Glossary of Terms at
Recruitment status: clinical study
Not yet recruiting: The study has not started recruiting participants.
Recruiting: The study is currently recruiting participants.
Enrolling by invitation: The study is selecting its participants from a population, or group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that particular population, who are specifically invited to participate.
Active, not recruiting: The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.
Suspended: The study has stopped early but may start again.
Terminated: The study has stopped early and will not start again. Participants are no longer being examined or treated.
Completed: The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).
Withdrawn: The study stopped early, before enrolling its first participant.
Unknown: A study on whose last known status was recruiting; not yet recruiting; or active, not recruiting but that has passed its completion date, and the status has not been last verified within the past 2 years

To: weatherproof who wrote (45935)4/28/2018 7:42:59 PM
From: drtom12346 Recommendations

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and 1 more member

  Read Replies (1) | Respond to of 58497
As I recall, while the basket study may have paused with TNBC, it always stayed "active" on the clinical trials website. Generally, when a trial gets changed to "active, not recruiting", it means that they are continuing to treat and follow the patients they have already accrued, but will not be recruiting further patients to the study. Generally, a trial will not go back to "active" once it's changed to "active, not recruiting". That's why I find this so confusing. To my mind, the cost of initiating new P2 trials when you had a perfectly good one running makes no sense. The two stage approach, assuming that is the plan, could easily have been done within the basket trial without added cost. So, again, as best I can tell, either they've already accrued enough to satisfy AA requirements, or, they aren't planning on applying for AA, and moving forward with a P3 in the standard way. I suppose another alternative is that they are setting up a P2/P3 study, where they finish off the P2 numbers they need for AA, then move straight into accrual for the confirmatory P3 while the application for AA is going through the FDA process. So, using TNBC for example. The initial basket study numbers to get BTD were, I believe around 58. If the company had gone the P2/P3 combo study route, they could have accrued the additional 42 patients requested by the FDA, and then zoomed straight into the P3 while AA was pending. Of course, the risk here is that if the 42 patients hadn't supported AA, you're on the hook for a P3 study, and have to eat the costs involved with shutting that down, or continuing it without moving forward with the AA application. Hopefully the company will offer some clarity in 36 days.