Ok I spoke to PAR...
"As previously announced, PAR will make a separate announcement in terms of the FDA Type C feedback when they are in receipt of it. Once we receive the feedback we will be detailing our clinical programs in the upcoming R&D day."
Mozz View:
At this stage it is PAR's estimates of how the trials will go. In truth, no one really knows this, even the FDA....what? It's true...it depends on hundreds of variable factors...the trial design, the components for the trial, what the FDA's feedback is in terms of the best plan forward and what is required, and how PAR implements the same. The guidelines. Then we must add all the external and unknown factors, how will recruitment go...what role does Covid play...are there further delays, are their acceleration's?
People, we are in the start up Bio Phrama industry...this is not uncommon...I understand communication is key, but as I said, it is PAR's own estimates, they can't keep updating the market every 5 minutes there is looking like some change, it is always their best guess at the time. AND better to UPOD of course.
As I have said a number of times, this is a longer term play, we aren't a one trick pony, it is a spec investment but mate, the long term play in my mind has not changed one bit....I agree it always isn't the best news to hear of further possible delays but if you can hang on, in my express opinion, what we have is compelling though not without ANY risk. Keep that in mind.
There is one more thing I want you to consider....why is it taking so long, why the constant set-backs, the delays? YOU are forgetting that we are hitting MORE than one market at a time through a few agencies all at once...We could've started our IND a while ago in Europe alone...we are harmonising the trials.Yes, it means we are gathering more info to make our first punch all the more impactful armed heavily with the exact plan for the HIGHEST chance of successful path to registration....not just in ONE market...MULTIPLE GLOBAL markets and all simultaneously. At the end of the day there might be a delay of a few months...but this is a MUCH faster path to overall global sales rather than hitting one market sooner and then in tandem going for the next market.
Let me tell you, if they have to add 6 months more..let them do it ..once we hit the world, there will be just no looking back...it will be explosive. We are cautiously gathering as much raw and beneficial information for the highest chance of successful registration and commercial success. That does it for me.
DYOR
- Mozz
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