banter and General Discussion, page-10167

JB, I am in denial?

Perhaps consider your own stance.

The company could not proceed with the BLA

The company is now proceeding again

How about we meet back here in a week when it either gets accepted or rejected?

By the way- my tag line was from this excerpt

TARGETED ONCOLOGY: Moving on to the August 13th ODAC hearing, can you share your thoughts on the data presented for remestemcel-L?

Hoffman: This was a very complicated decision for the committee. The morning sessions had a lot of science in it that many of us clinicians are not familiar with. The sponsor did do a good job in presenting that science in a way that could understood.

The key takeaway from these data were that although there had been prior randomized trials that did not show benefit, it seemed that changes had been made in the product that could have accounted for differences in activity. The bottom line was that the drug did work.

The sponsor was smart in getting Joanne Kurtzberg, MD from Duke Health. She was very articulate about explaining what these children are suffering, how serious of a problem GVHD can be and her experience with seeing this drug make a big difference. Then, we had corroboration of that from some of the members of the committee.

This was a meeting I went into not knowing how it would. The afternoon presenters who were clinicians did an excellent job of addressing the question in a forthright way. I think everyone on the committee felt that, because there were no new safety signals with this drug that were of concern and there was a need, the drug should be approved.

TARGETED ONCOLOGY: What was the key reason for your positive vote?

Hoffman: I voted yes, and I was surprised that there were an overwhelming number of members who voted yes. One member changed their vote at the end, and the vote became 9 to 1 instead of 8 to 2. That was a testament to the sponsor’s job of presenting the data and addressing the uncertainties raised by the FDA.
https://www.targetedonc.com/view/odac-continues-to-make-revolutionary-drug-recommendations-during-covid-19




Be open to change

Reg