Just to check that first link worked, I randomly clicked on it...I just read the first paragraph..
Par had a call to discuss the 12 month 008 results...first couple of questions were to Donna, see excerpt below.
We have never argued with the FDA, in fact we have not only obliged them but at every step of the way we have asked them politely for any help or guidance.
(PRE IND, TYPE D Meetings, using consultants that were Ex FDA, experts and KOL's).
We have really done over and above expectations, so many non clinical and preclinical studies, onerous monitoring protocols ...I hope now at least with the submission of excellent and first time seen evidence (008) they will give us a break and go a bit easier or at least not make the next step too onerous?
Read this:
QUESTION 1Why was the original 2 x 2 dose not included in the original study design?
Donna - We had a lot of experience with the 2 x 2 dosing when we went to the FDA. There was some discussion around whether we were working with the lowest effective dose and whether we were willing to add some lower doses into the study. Not including the 2 x 2 dosing was due to negotiations with the FDA around the findings of a single non clinical program involving some rats and adrenal effects. For that reason we had to reduce the dose while we were conducting studies to resolve those questions around that single rat study.
Now those studies have been conducted and we have resolved that the additional information that the FDA needed to see is now available showing that those rat findings were not relevant in any way. This opens the door for us to reintroduce the 2 x 2 dosing back into our program.
QUESTION 2
Given the FDA did not sanction the 2 x 2 dose originally, in your opinion does it allow PAR to use this dose in the 002 Stage 2 and 003 confirmatory study or will PAR need to conduct a separate stage 1 dosing arm for this dose before proceeding?
Donna - Well now that the optimal dose has been identified for proceeding, a further dosing arm will not be needed in our studies so going forward. Our task will be to introduce this dose into our Phase 3 program and we will come back to the market when we have worked out the details of exactly how that will be done.
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Ref:
008 - 12 Month data release Q & A......................................13/10/23
(20min delay)