In reality it's a very difficult job to predict announcements even as a rough.
I'm happy to take a stab but there is no way I would really know. Too many factors can sway things. Even if you work at PAR there is no way to know exactly when things can pan out let alone when and what announcements can be made. As an example the data on RRV came out literally months and months after it was first slated. Investors were actually thinking that there must be problems as the delay in the results were so great.With the focus well and truly on OA and MPS there isn't a focus on the DOD and RRV so this indication, while still brewing on the back burner, may take some time to get to the next stage?
Ok well we know the Pre IND is happening very soon. Im hoping there will be at least a high level summary some time after this meeting but don't hold your breath.My guess is the IND will take place a few months after that in terms of OA. Don't forget we now have not one but two jurisdictions we are tackling via EMA and FDA. I'm guessing the IND meeting will happen in the US but the EMA will get teleconferenced in? Not sure how that might work or whether PAR reps fly to two separate meetings? It sounds like there is some co-ordination between the two authorities so I'm guessing it might just be the one meeting to kick things off.
Great to read this line ... both agencies have agreed to hear our case in parallel.
I personally feel the IND meeting will be share price stimulatory but hey, buy the rumour sell the news may still apply? I'm not selling for a long long time so to some extent I don't care about the day to day fluctuations and trying to make sense of them. I like Rusty's philosophy - "Who Cares" and "Buy Buy Buy"...well it was a "Buy" a number of months ago..now it's getting harder as the price goes up but in my opinion it's still early days.. It will do what it does and just hold all through it and one day we really should accelerate.
In terms of the American footballers, I'm hoping the first dosage of the first player is happening as I type this, this will be staggered for the rest of the other 9 patients and by the time the results are compiled I can easily see us in May or even June. This will be a big announcement and the ensuing publicity if done properly could be quite material.I'm guessing most investment funds and a good slice of the general public may hear something about us over in the US at that stage, the majority for the first time. We could very well start to get reported in a lot of media and there won't be enough sellers to fulfil those new and existing buyer orders. This is of course my views.
There could also be some ancillary news such as the SAS next batch results and some Peer reviewed material but your guess is as good as mine as to when that might be released.As far as the TGA is concerned I would think within a month from now we should get either the go ahead or the non go ahead, yes I'm err'ing on the go side. I mean Go in terms of we can officially start the Provisional application process.I still think early Q4 is sort of realistic as to when we might actually have permission to sell iPPS in Aus. It could take a little while to actually get it going so it might be more the end of the year before we register some sales? Will be a super Christmas present for us if it pans out in this fashion
Finally on top of all that above (as if that's not enough), we have MPS and this too is in both areas, US and Europe, gosh a lot on our plates. This will also be going in parallel to everything else. Being an Orphan designation we could see things happen in this area on a possibly more accelerated pathway.
Lots to come, as I said just my views here, I could very easily be wrong in terms of timings but this is what I'm thinking today. DYOR - it's all speculative and no one really knows timings. Should be an amazing next two years let alone the future.
(20min delay)