Ann: US FDA Type C Meeting for ATL1102 in DMD, page-58

Ok so lets try to clear up this uncertainty

As in

Yes, most of us here quite confused about the Non-Clinical Requirement... But if you try to read through from the above-mentioned links, you are probably clear your doubt a bit..

So in actual fact

Animal Studies (also called nonclinical data).
studies that provide the first data
to support the Initial safety in
testing humans


Partial clinical hold.
The proposed trial may proceed only with restrictions that FDA will
describe in their letter to the sponsor.

If FDA places your IND on a clinical hold,

The Company would work with the FDA to resolve the deficiencies.

They should prepare and submit a response to the critical issues that led to
the clinical hold.

There may be a need to submit additional NONE CLINICAL DATA
explain existing data, or modify the protocol to ensure patient
safety

ATL1102 as far as the FDA is concerned is in a partial hold with a max dosing of 25mg this is an issue they obviously have to address

I am not saying we are not going to move forwards in our trials

But unlike others here that believed one trip to the FDA and it would be plain sailing obviously, not going to be that simple

People ask for facts but but when facts are presented some folks find them hard to swallow

I tend to research not what is said in ASX Ann but what is not said in these Ann

Optimistic pessimistic realistic

The facts are the facts and ANP have a few issues to work through, which is all i have ever stated,

I got from that ANP Ann all i was expecting,

Guidance for ANP to move forwards into into the Ph2b 3 trial which i am sure they will get on what sort of a time frame remains to be seen

Enjoy your Wkends

I will be at the bottom of my driveway tomorrow morning