Ann: US FDA Type C Meeting for ATL1102 in DMD, page-39

Agree Phlipper,

This announcement supports and co-incides with all we hoped for clinically. The lack of anything mentioned about clinical issues confirms this. Sam, you may have just got your validation.

As for non clinical - to me the underlying message from the FDA to ANP is "it looks great, hurry up and get this going". FDA do not want to see a great drug commence trial but without the financial support and managerial capablity to see it through to market. That's part of the reason the PRV exists for ODD's. The timeliniess of adding Dr Charmaine now appears visionary.
Now the what, where, when, how become the spotlight items. But the biggest "non clinical" decision of all trials...... how much will it cost and who gets to participate ??

Very positive for me. Happy friday indeed.