As I said before, all the information that you need to know pertaining FDA process/guidance are at their website.
Please refer to the following link:
https://www.fda.gov/patients/drug-development-process/step-2-preclinical-researchhttps://www.fda.gov/patients/drug-development-process/step-3-clinical-researchYes, 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..
From the announcement, the key word that caught my attention is
"CONSTRUCTIVE". To me,
if it ain't positive, it ain't constructive, simple as that.
so, to be constructive, both parties must have clear understanding, goal and objective. As I pointed out before, the Type C Meeting was requested by Dr. G Price, and he should have well-prepared the requirement/info.
" Non-clinical requirements are to be
further reviewed and agreedwith the FDA" - It could be dosing, number of frequency use...single-dose/repeated-dose.. and adverse effect etc... listen to Dr. G. Price recent interview if you don't mind... basically he has already knew what's the concern from FDA.
“Based on the guidance meeting with the FDA, together with prior
feedback from EMA and world leading DMD experts, we are
reassured that the data from our Phase II study is encouraging and that it is
reasonable and appropriate to advance the program towards potentially pivotal clinical studies. It is our goal to bring this medication to as many DMD patients worldwide as possible”.
To me , I have confident about it.. Listen to Dr. G. price interview, it's all about
Clinical Trial Data. "
Making sure we have data that is robust that will convince the scientific community and regulatory community that we have something here that is beneficial." Didn't we have robust data from Phase IIa and all the statements from the scientists/DMD Experts?
If ATL1102 outcomes in Multiple Sclerosis
clinically validated (with higher dose) and support development of ATL1102 in DMD (with lower dose)
and ATL1102 in DMD now also proved to meet primary endpoint and
EXCEED expectations on secondary endpoints... so i don't see any adverse effect and any major setback from FDA. It's probably just a "minor touch up" that's all.
As I said, I'm happy with the announcement because it is constructive. I'm still remain optimistic about the meeting outcome. (Note: This is just my opinion)
