Theriva Biologics Inc (TOVX)

[Seel]

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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.