7 results
10-Q
2024 Q1
GUTS
Fractyl Health Inc.
13 May 24
Quarterly report
4:06pm
in or failure to obtain IRB or ethics committee approval at each site;
delays in or failure to recruit suitable patients to participate in a clinical study … the clinical trial takes place, to both the competent national health authority and an independent ethics committee, the CTR introduces a centralized process
10-K
2023 FY
GUTS
Fractyl Health Inc.
1 Apr 24
Annual report
7:15am
;
submission to the FDA of an IND, which must become effective before clinical trials may begin;
approval by an IRB or ethics committee at each clinical … and an independent ethics committee, much like the FDA and IRB respectively, the CTR introduces a centralized process and only requires the submission
424B4
GUTS
Fractyl Health Inc.
2 Feb 24
Prospectus supplement with pricing info
4:18pm
to extensive negotiation and may vary significantly among different clinical study sites;
delays in or failure to obtain IRB or ethics committee … the competent national health authority and an independent ethics committee, the CTR introduces a centralized process and only requires the submission
S-1/A
GUTS
Fractyl Health Inc.
29 Jan 24
IPO registration (amended)
6:09am
in or failure to obtain IRB or ethics committee approval at each site;
delays in or failure to recruit suitable patients to participate in a clinical … trial takes place, to both the competent national health authority and an independent ethics committee, the CTR introduces a centralized process and only
S-1
GUTS
Fractyl Health Inc.
14 Dec 23
IPO registration
3:39pm
different clinical study sites;
delays in or failure to obtain IRB or ethics committee approval at each site;
delays in or failure to recruit suitable … in each member state in which the clinical trial takes place, to both the competent national health authority and an independent ethics committee, the CTR
DRS/A
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21 Sep 23
Draft registration statement (amended)
12:00am
DRS/A
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22 Aug 23
Draft registration statement (amended)
12:00am
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