Can an AML study be announced before 2nd interim review?

[robtmsstt1]

Or is this just to inform shareholders on this study if done and what imetelstat will be used with if an AML study was to move forward?

[Fishermangents]

Hi rob, I don't think an AML trial will be anmnounced before Q2 review. This is for two reasons: JnJ wnats to include all data of the current trials (IMbark, IMegre, Mayo Pilot) to be included into the decission making of any AML trial, especially regarding dosing (see email Anna). Secondly, my guess is that with the presentation of the full imetelstat program to a regulative authority (has been announced various times by Scarlett) they firts would like to receive the feedback from this authority. from the latest 10-K:
"We expect Janssen's decision-making regarding IMbark, IMerge, the imetelstat program or the Collaboration Agreement to occur in the second quarter of 2017. Janssen's decisions regarding future development plans for imetelstat, if any, may be subject to subsequent regulatory feedback."

My estimation is that an announcement of any new AML trial will not before the end of Q2. However, depending on how successful the Q2 review will be and how will this regulative authority will respond, an announcement of an AML trial could happen 2H of this year, meaning that enrollment for such a trial could start in 2018, as per Anna's email.

[robtmsstt1]

Thanks, fish im just trying to figure why do the presentation on the 3rd unless some pertinent news will come of it about the AML study.

[biopearl]

robtmsstt1, Agree with Fish. The AML study is a preclinical study to be formally presented at a scientific meeting. It will provide some of the rationale for future clinical studies. J and J has made it clear that they will look at information from the MF/MDS clinical trials and also use this information especially as it relates to dosing before finalizing a clinical AML trial which undoubtedly lies somewhere ahead, just not as soon as you are looking for. bp