Greta:
Sincere sympathies. My major professor, a second father in my eyes, died of ALS. I was alone with him when he had his first seizure. He was a man's strong man, in every meaning of the phrase. A cruel disease.
Why do you label Myotrophin as "drug" rather than as "molecule"? Preconception? Data?
There's no shame in FDA's camp, Greta. None. They are trying to display scientific integrity and do an unpleasant job that needs doing. Further, they have not rejected the molecule. An INDEPENDENT advisory committee, comprised of experts, determined that the data was not sufficient for approval. It would seem, with "conditionally approvable", that FDA is walking a middle course.
I'm not going to participate further in this discussion. On occasion, I feel like being supportive of a regulatory agency that seems, to me, to be doing a decent job.
Rick |
