Agree, given what we know about the proposed adult trial, enrolment of the very sick as a third line therapy, it would fail to have a concurrent control as all but a very few would go with the off label use. So given approval in children this trial will need to undergo a significant protocol change to a comparative tial as a second line therapy. So it is in MSBs interest to delay.
The August time line seems to be making a lot of assumptions. First they seem to think that the BLA will take the full quarter to resubmit. What is there to do? It may well be done this month so approval could be this quarter given a 60 day review or by year end given a 6 month review.
On a side note, US lead short problem is continuing to develop. Interest on new borrowing has gone up to 50%!! They are desperate to get stock. They don't want to buy on market as this would see the SP rise at similar speed to what we have just seen.
They are trying to buy time by filling calls with new borrowed stock. 50 % sounds great but what do you get if the shares are covered in just a couple of weeks or for that matter days.
We know that we will have a announcement at end of this month, minutes and or quarterly report but if anything comes a bit beforehand while shorts are still playing games the SP will go north. Good luck all.
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