#Blockbuster
It's obvious that Prof Voit has had critical input into the "PIP" design.
At 46:30 Shayne asks the Prof. if ATL1102 could be used in patients that are still ambulant?
Prof Voit says:
"Oh yes absolutely, and WE have already discussed how to draw up the Pediatric Investigational Plan...this is something you would want to use as early as possible..."
"...even before the age of 4 years, the question is how you structure the trials showing this...definitely will be beneficial.."
The work ANP has done to clarify the Mechanism of Action is also poignant when considering the Prof's comments:
"Proof of mechanism is something regulators bang on about..."
You can bet ANP's PIP submission to EMA would have contained the rich proteomics data outlining the MoA.
Explains why in March the Diamond mentioned Prof Voit was going to be PI for Phase IIB.
...and the link to Sarepta's micro-dystrophin patents
Not long to go until we get clarity.
.
#Blockbuster It's obvious that Prof Voit has had critical input...
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