Replies to post #74040 on Ayala Pharmaceuticals Inc (ADXS)

[mm2k]

Not sure I agree it's completely dead. I think the feedback from the EMA was clear, and the only option right now was to pull the application, even if a partnership is imminent. Any partner will have to get the additional data, one way or other, and refile. I still agree a partnership is either a long shot or not likely to provide significant up front money, but there may still be a partnership that can alleviate ADXS of some of the costs.

[jckrdu]

IMO, you can't connect the two.

EMA gave their decision so Ken really had no choice but to withdraw the application for EU conditional approval.

IMO, partnering the AXAL program is another story: They have an SPA for the Phase 3 AIM2CERV trial. That has value. Question is, is there enough value to strike a partnership? I'm taking Ken at his word that he's still looking for an AXAL partner. He wouldn't still be looking if he didn't think it was possible to partner AXAL. IMO, it can go either way... partnership announced before end of year or Ken announces AXAL for cervical/AIM2CERV is winding down. Update in September.

Based on today's news, I sold half my position in pre-market. Holding the other half because I think eventually the pps will recover somewhat... either as a smaller company focused on Neoantigen based therapy where they're under-valued versus peers, or with Neoantigen focus plus AXAL/cervical partnership in Phase 3.

[James salmon]

You could not partner, without disclosing that EMA required more data.

The fact that the phase 3 still continues does not indicate at this time that AXAL has been shelved, far from it.

[ignatiusrielly35]

You are failing to distinguish between pulling an application for early approval based on a Phase 2 study and continuing with Phase 3 of a different study.