The work plan details the steps KV is taking to resolve its manufacturing deficiencies. Following its review by the US Food and Drug Administration (FDA) additions were made to the work plan.
KV has accepted these modifications and had begun implementing the plan prior to its acceptance by the FDA, according to a company filing with the US Securities and Exchange Commission (SEC). The agency was informed of KV’s actions.
Implementation of the work plan and rehiring of some employees are part of KV’s efforts to resume commercial manufacture. The verification batches are being produced by the rehired staff under the supervision of independent consultants to help KV enhance its manufacturing processes and regulatory compliance.
None of the products currently being produced will be distributed commercially. KV anticipates it will resume shipping during or after the fourth quarter of calendar year 2009.
Before this can occur the consent decree states that KV’s facilities, policies, procedures and practices must be reviewed by an independent expert to ensure they comply with current good manufacturing practices (cGMP).
KV anticipates that it will request that Lachman Consultants, an independent cGMP group, to perform the review later this year. If this is successful the FDA will inspect the facility, after which shipments could be allowed to resume.
Release of the SEC filing resulted in KV’s share price finishing the day up over 31 per cent.
The SEC filing also details the efforts KV is making to raise capital. A financial boost is being sought to meet ongoing operating costs, refinance existing obligations and to fund the acquisition of the rights to Gestiva (17-alpha hydroxyprogesterone).
KV has retained Robert W Baird & Company to advise on raising capital but acknowledges that in the current environment it may be challenging.
In addition to the challenging credit market KV faces uncertainty about the resumption of shipping and the outcome of ongoing government investigations.