Teligent, Inc. (NASDAQ:TLGT) Q3 2019 Earnings Conference Call - Final Transcript
Nov 04, 2019 • 04:30 pm ET
we go from here? It sounds like you're ahead of plan so far year-to-date, feel comfortable with the guidance that you provided this year from a gross margin perspective, but what will that mean getting those incremental products launched out of that facility? Thank you.
Yeah. Thank you. So if you look at the way the facility is currently structured. Obviously, the total cost of the shared services that support both sterile and injectable manufacturing are being born in that facility today. That should imply that there will be some uplift in gross margin as we get into launching further injectable drug products in 2020. The magnitude of that will depend, of course, on product mix, the competitive dynamics of those markets as we enter them. But as we have a better sense of that nearing the time, we'll be able to give better insight and guidance around that. And thank you for the question.
Thank you. And our next question comes from the line of Scott Henry with Roth Capital. Your line is now open.
Thank you and good afternoon. Going to start with a couple of follow-up questions. Just with regards to ranitidine, will you get a GDUFA date for that or have you gotten a GDUFA date? And then as well with regards to the follow-on filings, the eight to 10, do you have to wait until after the inspection or is that something you can do prior to that? Thank you.
So with respect to the timing of the supplement, we should receive a GDUFA date for that supplement. I believe that, that's probably five months from the date of our submission. Now that being said, remember that this is a drug that we had already agreed with FDA prior to the NDMA question to review the product simultaneously with the generation of stability data, as a result of the drug shortages that had been present in this molecule in the past. So that is still our regulatory pathway with FDA on this product and we expect that they will be able to review and inspect that data concurrently with its generation.
As it relates to the subsequent filings, because they are not filings which are on an accelerated basis with stability data being reviewed concurrently, but are instead traditional supplements or traditional new ANDA filings, they require us to generate the appropriate length of stability data to be able to support the application.
You will remember of course that in the form of the supplements, we're required to submit three months of stability data to the FDA to support a site transfer, with respect to a new ANDA, would require six months of stability data. So I think that, that data will continue to be generated and will be present pretty much along the same time line as the FDA inspecting the facility for the ranitidine application, which means we would probably submit them already knowing the disposition of the facility inspection.
Okay. Great. Thanks