Company statements about clinical trials, they have admitted to cooking the books before, and are under FDA scrutiny. This is from latest company filings so this is current information, I guess the FDA moves as slow as other governement agencies
In June 1995 the Company notified the FDA that it had submitted incorrect
efficacy data to the FDA pertaining to its Phase II dose-ranging studies of
BCX-34 for CTCL and psoriasis. The FDA inspected the Company in November 1995 in
relation to a study involving the topical application of BCX-34 concluded in
early 1995, and in June 1996 the FDA inspected the Company and one of its
clinical sites in relation to a Phase II dose-ranging study of BCX-34 for CTCL
and a Phase II dose ranging study for psoriasis, both of which were concluded in
early 1995. After each inspection, the FDA issued to the Company a List of
Inspectional Observations ("Form FDA 483") setting forth certain deficient Good
Clinical Practices procedures followed by the Company, some of which resulted in
submission to the FDA of efficacy data which reported false statistical
significance.
The FDA also issued a Form FDA 483 to the principal investigator
at one of the Company's clinical sites citing numerous significant deficiencies
in the conduct of the Phase II dose-ranging studies of BCX-34 for CTCL and
psoriasis. These deficiencies included improper delegations of authority by the
principal investigator, failures to follow the protocols, institutional review
board deviations, and discrepancies or deficiencies in documentation and
reporting. The Company received notice from the FDA in November 1997 that work
in support of products under FDA jurisdiction performed by this investigator
would not be accepted by the FDA without validating information. Currently, the
Company does not intend to pursue a topical treatment for BCX-34, which is the
clinical study this investigator pursued for the Company. As a consequence of
the FDA inspections and such resulting Form FDA 483s, the Company's ongoing and
future clinical studies may receive increased scrutiny; this may delay the
regulatory review process or require the Company to increase the number of
patients at other sites to obtain approval (which cannot be assured on a timely
basis or at all). |
