I got this from a Yahoo Finance. Basically good new but it takes time.
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. ...Type A meeting to discuss and gain clarity on the issues outlined in the CRL.
Path Forward
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.
medac will need to 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.
Basically we are looking at 4 to 8 months before this gets through the highly political and run by idiot lawyers FDA. This is medac's problem.
In the mean time we can count on sales for Canada and Management needs to focus on generating sales from existing products and bring on new ones.