Nabriva Therapeutics PLC – ADR (NASDAQ: NBRV) shares traded higher last week after the micro-cap biotech said it requested a Type A meeting with the FDA regarding the complete response letter for the new drug application for its investigational compound Contepo to treat complicated urinary tract infections, including acute kidney infections.
The FDA shot down the regulatory application in early May, citing issues related to facility inspections and manufacturing deficiencies at one of Nabriva's contract manufacturers.
Why is the news of the Type A meeting request triggering renewed interest in Nabriva shares?
Type A Meetings
The FDA and the applicants of regulatory filings interact with each other during the review period regarding advice relating to the development and review of investigational new drugs and biologics. Four formal meetings occur during the PDUFA review period: Type A, Type B, Type B (end-of-phase) and Type C.
Type A meetings are necessary for proceeding with a stalled product development program or addressing an important related safety issue, according to the FDA.
Usually, the sponsor of a drug requests a Type A meeting to discuss clinical holds, seeking inputs as to how resolve the issue, or following the submission of a response to the hold — if the FDA and the sponsor deem that the development is stalled and a new path forward is to be discussed.
Before submitting a request, the sponsor has to contact the review division to discuss the appropriateness of the request.
The FDA schedules a Type A meeting with the sponsor within 30 days of receiving a request.
When a CRL is issued, companies usually file a resubmission. Nabriva has said it sought a Type A meeting to discuss and gain clarity on the issues outlined in the CRL.
Following a Type A meeting, companies typically take the feedback from the meeting and use it to address the issues impeding drug development or approval.
Nabriva said it will resubmit the NDA after it receives the minutes of the Type A meeting, which will be issued within 30 days of the meeting being held.
Once the resubmission is complete, the FDA will communicate its response within 30 days.
The resubmissions will be classified either as Class I or Class II resubmissions, with the decision coming through in two months for the former and six months for the latter.
Nabriva shares closed Monday's session down 4.98% at $2.10. The stock turned positive in after-hours trading and was higher by 2.86% at the time of publication, on positive news from the European market.
The company announced after the close that the European Medicines Agency validated its marketing authorization application for intravenous and oral lefamulin, an antibiotic targeting community-acquired pneumonia.
The validation means the company's submission is sufficient to begin the formal review process, according to Nabriva, adding that an EMA Committee for Medicinal Products for Human Use opinion is expected in the next 12-15 months.
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