PharmaCyte Biotech Inc (PMCB)

[tyscty]

FDA Pre-IND meeting....

I have read on here that we are looking at 30 days from the time we requested the meeting until we have one with the FDA. However, according to the FDA's guidance package found at insert-text-here We are looking within 60 days. So maybe just a little longer. Maybe can allow a few of us to save some more money before this thing takes off. Go $PMCB! Anyways just wanted to pass this along. Read below or click on the link.


B. Type B Meeting
Type B meetings are as follows:4
• Pre-investigational new drug application (pre-IND) meetings (21 CFR 312.82)
• Certain end-of-phase 1 meetings (21 CFR 312.82)
• End-of-phase 2 and pre-phase 3 meetings (21 CFR 312.47)
• Pre-new drug application/biologics license application meetings (21 CFR 312.47)
Type B meetings should be scheduled to occur within 60 days of FDA receipt of the written
meeting request. If a sponsor or applicant requests a meeting date that is beyond 60 days from
the date of request receipt, we will work with the sponsor or applicant to determine the earliest
agreeable date.
To promote efficient management of formal meetings, the requestor should try to anticipate
future needs and, to the extent practical, combine product development issues into the fewest
possible meetings. Generally, we will not grant more than one of each of the Type B meetings
for each potential application (e.g., investigational new drug application (IND), new drug
application (NDA), biologics license application (BLA)) or combination of closely related
products developed by the same sponsor or applicant (e.g., same active ingredient but different
dosage forms being developed concurrently), but we can do so when it would be beneficial to
hold separate meetings to discuss unrelated issues. It also may be appropriate to conduct more
than one of some of the Type B meetings for concurrent development of a product for unrelated
claims.