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By: riffypa
16 Mar 2004, 10:34 PM EST
Msg. 143766 of 143772
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Since the Israel trials are almost complete, I am sure that the company is getting ready to submit an IND application for injectable AVR118 for HIV salvage therapy patients. I believe the goal will be to use the Israel data to support the IND and possibly start US (FDA) testing at Phase II.

Pasted below is the FDA regulation that provides data on using foreign studies to support a US FDA INDA. It appears that if the study is properly conducted the FDA will accept the data. Hopefully more news concerning this subject will be coming soon and AVR118 can finally start its journey with the FDA clinical trial process!

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)

PART 312--INVESTIGATIONAL NEW DRUG APPLICATION--Table of Contents

Subpart F--Miscellaneous

Sec. 312.120 Foreign clinical studies not conducted under an IND.

(a) Introduction. This section describes the criteria for acceptance
by FDA of foreign clinical studies not conducted under an IND. In
general, FDA accepts such studies provided they are well designed, well
conducted, performed by qualified investigators, and conducted in
accordance with ethical principles acceptable to the world community.
Studies meeting these criteria may be utilized to support clinical
investigations in the United States and/or marketing approval. Marketing
approval of a new drug based solely on foreign clinical data is governed
by Sec. 314.106.
(b) Data submissions. A sponsor who wishes to rely on a foreign
clinical study to support an IND or to support an application for
marketing approval shall submit to FDA the following information:
(1) A description of the investigator's qualifications;
(2) A description of the research facilities;
(3) A detailed summary of the protocol and results of the study,
and, should FDA request, case records maintained by the investigator or
additional background data such as hospital or other institutional
records;
(4) A description of the drug substance and drug product used in the
study, including a description of components, formulation,
specifications, and bioavailability of the specific drug product used in
the clinical study, if available; and
(5) If the study is intended to support the effectiveness of a drug
product, information showing that the study is adequate and well
controlled under Sec. 314.126.
(c) Conformance with ethical principles. (1) Foreign clinical
research is required to have been conducted in accordance with the
ethical principles stated in

[[Page 83]]

the ``Declaration of Helsinki'' (see paragraph (c)(4) of this section)
or the laws and regulations of the country in which the research was
conducted, whichever represents the greater protection of the
individual.
(2) For each foreign clinical study submitted under this section,
the sponsor shall explain how the research conformed to the ethical
principles contained in the ``Declaration of Helsinki'' or the foreign
country's standards, whichever were used. If the foreign country's
standards were used, the sponsor shall explain in detail how those
standards differ from the ``Declaration of Helsinki'' and how they offer
greater protection.
(3) When the research has been approved by an independent review
committee, the sponsor shall submit to FDA documentation of such review
and approval, including the names and qualifications of the members of
the committee. In this regard, a ``review committee'' means a committee
composed of scientists and, where practicable, individuals who are
otherwise qualified (e.g., other health professionals or laymen). The
investigator may not vote on any aspect of the review of his or her
protocol by a review committee.


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