Review or not to review.

[jayfish101]

Dr. S. seems to be saying there may not be a review. It could get cancelled and I would hope that means moved to the approval stage.

John Scarlett: Yes. Thanks, Faye. I think I'd like to make a couple of other points about the ODAC. Just to remind people we were told that the FDA is planning an ODAC, but we don't know if that will actually occur. There's historical. There's historical information about other products in which ODAC had been planned. They've actually been scheduled and they've been cancelled last minute. So I think we'll just have to wait and see on that. We often get a question, Craig, about when did the most ODACs occur? I think in general, our research shows that they occur four to six weeks before the PDUFA date something like that. And I think the other comment is that we have a variety of consultants. So as well as the consultant that Faye was describing who is a very specialized ODAC and advisory committee, consultant. We have other broad, regulatory consultants. So I think we feel like we will be very prepared through this process for whatever may come and as we've commented in the past, and she commented today in her prepared remarks, I think we look forward to discussing the opportunities for treatment with imetelstat in the space.

[biopearl123]

Jay, we were also led to believe priority review was a strong possibility. It didn’t happen. It’s not impossible that the FDA will just approve outright but I wouldn’t hold my breath.

[KTArsenal]

The FDA's intention is to learn sooooo much more about imetelstat because apparently, the FDA has been out to lunch since 2018 and their Michelin-starred lunch tabs have been picked up by a couple of (insert ticker symbols here) pharmaceutical companies ever since.

[LWS]

Advisory Committees and the Oncologic Drugs Advisory Committee (ODAC)

Advisory Committees help the FDA to review new drug approvals. These organizations are generally made up of around a dozen experts in a broad field of medicine, such as endocrinology, reproductive health, or medical imaging. Membership typically includes one (voting) member with ties to consumer interests and one (non-voting) member with ties to industry interests. While these committees do not ultimately decide whether or not a new drug is approved, they provide the FDA with expert recommendations and perspectives, helping regulators to better understand how a new drug is viewed by the professionals most likely to use it. Between 2001 and 2010, the FDA approved about 88% of applications supported by advisory committees and rejected about 86% of drugs not supported by advisory committees.

The Oncologic Drugs Advisory Committee, or ODAC, is the advisory committee responsible for making recommendations concerning new cancer drugs. Its membership includes experts in general oncology, pediatric oncology, hematologic oncology, immunologic oncology, biostatistics, and other related fields

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We are waiting for the ODAC (or Oncology ADCOM) to either schedule a meeting or decide that Imetestat has demonstrated and proven enough about its safety and capacities, that no further action is needed for the NDA approval. The ball is now completely in their court. I don't believe we will know until after ASH2023.

If anyone (with creditability) has anything negative to say about Imetelstat, as a blood cancer medicine, I haven't seen it posted on this board. Imetelstat is ready to go, and is needed now with full approvals, beyond the operational EAP.
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John Scarlett: Yes. Thanks, Faye. I think I'd like to make a couple of other points about the ODAC. Just to remind people we were told that the FDA is planning an ODAC, but we don't know if that will actually occur. There's historical information about other products in which ODAC had been planned. They've actually been scheduled and they've been cancelled last minute. So I think we'll just have to wait and see on that.

We have other broad, regulatory consultants. So I think we feel like we will be very prepared through this process for whatever may come and as we've commented in the past, and she commented today in her prepared remarks, I think we look forward to discussing the opportunities for treatment with imetelstat in the space.