My prediction is that the FDA will use all 30 days to respond and PAR will likely receive the FDA response on Friday night July 30th our time with a likely ASX announcement date being Monday August 2nd.
As has been posted by others on this forum I think there are 3 possible announcement scenarios:
Scenario 1. The agency advises that the IND status is now Open
Scenario 2. The agency has a minor query concerning PARs response submitted on June 30th. Such a query would presumably be able to be responded to without too much additional delay.
Scenario 3. The agency advises that they still have outstanding concerns which have not been resolved by PARs June 30th responses. It becomes apparent to the company that the outstanding concerns are best resolved by an additional non-clinical study. An additional study would likely delay our IND opening by potentially a number of months.
Based on my views I have assigned estimated probabilities for the occurrence of each of three scenarios as follows:
Scenario 1. 75%
Scenario 2. 15%
Scenario 3. 10%
I am also speculating a SP movement at the end of trading on the day of the announcement for scenarios 1 and 3 as:
Scenario 1 +40% or $2.80 based on $2 opening price
Scenario 3 -30% or $1.40
I think scenario 2 will result in a SP movement somewhere between Scenario 1 and 3.
Obviously I would expect the SP to trade much higher as we progress through Phase 3.
I am long term holder and still think the company will succeed even if scenario 3 is the outcome at the end of the month.
What does everyone else think in terms of end of day SP for scenarios 1 and 3?
As always DYOR and good luck to us all
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