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Re: So.............Conf Call UpdatesThere were a few pieces of useful information on this call but here is a summary from my memory of it. Most of it we already know about: 1. TDAPA was discussed and how important it is to get Defencath paid for outside the HD bundle and TDAPA is the way to do it. It was stated they can't apply for this until after approval and CMS makes these decisions once per quarter so you can expect a decision roughly one quarter after approval depending on the timing of the approval. 2. They have requested priority review as expected and as the FDA has told them they qualify for. If granted the PDUFA date should be 6 months instead of 10. The PDUFA date is a goal and approval can happen sooner or later than PDUFA date 3. They have spent significant money on heparin which would seem to indicate they are confident of approval and in quick sales. Since heparin is somewhat in short supply this is a wise move. 4. They are open to partnership and/or buyout but have never publicly said if any discussions were ongoing. I thought the wording of this was interesting. "We have never publicly stated we are in talks" (paraphrase) could mean they have said this privately? 5. They have cash to last to about 12 months from now. 6. Phoebe seemed pretty confident with the back and forth with the FDA via rolling submission that they had a good submission. 7. I found the PR interesting where it said mentioned rolling NDA submission "and review".....could that mean we get an early decision? 8. They continue to pursue approval for oncology / TPN, etc... |
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Msg # | Subject | Author | Recs | Date Posted |
40436 | Re: So.............Conf Call Updates | longek71 | 16 | 8/11/2020 6:03:57 AM |
40448 | Re: So.............Conf Call Questions not asked | hayfarmer | 17 | 8/11/2020 11:50:18 AM |