From IR . Nothing definitive, but well written response. At least they responded. Kudos for that.
We are reticent to give a prediction of when the IND will be filed. This is because even though everyone in the Company and those of our associated companies is working as diligently as possible to assemble the IND “package” as quickly as possible, we want our IND to be as “solid” and complete as we can possibly make it. However, studies that will be included in the IND are still going on and, as is the case with R&D in general, sometimes studies must be repeated and therefore the timeline gets stretched. Also, because such studies are being done by other companies for us, we cannot control the way such studies are done and the timing of them because they may be involved with studies for other companies as well.
We have already experienced problems that can occur that are totally out of our control. You may remember that in 2017 we lost essentially 6 months from our timeline simply because we could not obtain the proper growth medium for the cells that we use for the population of our Master Cell Bank and then used for encapsulation because the single supplier in the world (a major company) was unable to produce it according to specifications and although we tried to adapt our cells to other media, we were unsuccessful. This is one example of something that can vastly affect a development timeline. We do not wish to infer that such huge ‘timeline-altering’ problems will occur again before the IND is filed, but we know that some smaller delays may yet occur, and these will alter the timeline – thus our reticence to predict when the IND will be filed.
As for the involvement of TD2 – no, they will not be involved in conducting the trial. This was essentially their decision because they did not believe that they had enough infrastructure to coordinate the conduct of a trial like the one we will be doing. TD2 is more suited to coordinating the conduct of Phase 1 and early Phase 2 trials.
Message Body:
Later this year ??
Come on !!
December ???
Give us a reasonable range of dates for IND.
Is td2 back in the picture?
--
