Good question if discontinuing investigational mono trial means company cannot transfer any of these pts to new pivotal? Also since overlap is less with HAART in these pts , it may not be bad to have their data in new pivotal since it shows that efficacy can be still be met with most patients even if they don't stick to proper compliance and slack off on their HAART once they start leronlimab. Maybe the best option is to have all new patients for pivotal but reduce patient number needed and/or length of treatment to 24 weeks. Essentially this would be giving Cydy partial credit for the invest mono trial. Other question then becomes if invest mono stopped, do these patients get to stay on leronlimab as extension study? Some language to that effect I believe in trial protocol for patients who complete the 48 weeks, but many of these patients won't complete 48 weeks if trial stopped early. It may also be a financial burden to company to continue all these patients on leronlimab, while also not being able to include them in any trial data relevant for approval. At the same time, morally wrong to stop drug in patients for whom it is working.

With regards to delay in BLA for combo due to 700 mg safety data, this may not end up being a bad thing. I think patent life for biologics differs from regular drugs in that you have 12 years from first approval indication, but you cannot extend the patent with subsequent approval indications. In this case rapid approval in succession for multiple indications will give company maximum patent life for it's total addressable market. This is just what I have heard, so maybe worth someone checking on this.