I finally got around this morning to listen to the third quarter earnings conference call which was recorded on Nov 3. If interested, you can find a link under the investor relations section. Here are a few items of note for users:
A response to the FDA will be filed on Nov 21 for the new pod. Approval in the first quarter of 2012 appears to be the most likely outcome. The new pod will go into production sometime in the fourth quarter and will begin shipping in Europe early in the first quarter of 2012.
A new PDM will be supplied to existing customers at no cost when the new pods ship.
A submission to the FDA for the integration with DEXCOM has to wait until Dexcom receives approval for their next generation CGM.
Insulet experienced a delayed in product shipment at the end of the third quarter. It appears that they found a problem with one of the components (a 5.5 cent item). Hopefully this will address some of the failure issues that some of us have been experiencing. This discussion comes at the very end of the conference call.
I see that shipping in Europe was mentioned, but was there any mention of when we might expect to receive the new pods in the US? Thanks for the info!
Per the conference call, they expect that approval will most likely be received in the first quarter. There is an outside chance that approval could come this year, but that would mean that the FDA did not have any follow up questions to the submission on 11/21/11. They anticipate that the new pod will start shipping the first quarter but it all depends on how quickly the FDA grants approval.
Thank you so much, Larry. That is wonderful news.
I talked with one of the Reps on Saturday and they assured me that the new pods are already in production. I have to assume that means they're pretty sure of approval and we're just waiting for the last of the paperwork. The Rep also confirmed the pod issues and actually handed me a box when I complained about a bunch of occlusion errors I hadn't been able to get replaced. (7 out of 10 pods "occluded" after delivering between 75 and 90 units of insulin, always during a bolus, most of the time there was no kinked canula or blood...). He did say the problem was fixed so pods going out now should be good!
I have no knowledge other than what is on the conference call. The presenters were the Chief Executive Officer and the Chief Financial Officers so I would be surprised if they are in production. Of course, whether or not they are in production doesn't matter to a US user until FDA approval. They have European approval so production should begin shortly for a early 2012 roll out per there comments to analysts.
Thank you, Larry. This was quite useful.