Post by
beechguy on Jul 14, 2015 3:03pm
Off label use for MCNA
Let's all play nice. Off label is definitely something Urologist would gravitate towards given the highly unstable and dangerous live pathogen BCG. Dr. Berendt cannot comment on off label as not only can the FDA scuttle the BLA submission, but Telesta could be fined as almost all of the big pharmas have been (I believe Pfizer was fined 100mm for off label promotion) I know of a Urologist that will not prescribe or treat patients with BCG because of the danger to not only the patient, but to the person administering it. Graeme (take with a grain of salt) said at an AGM that a patient had had unprotected sex with his wife shortly after a BCG treatment, and she had to have a hysterectomy. The million dollar question is whether or not insurers would cover first-line off label use. I believe in phase 1 or 2 Telesta had some treatment-nave patients and had astounding results. Over 60% CRR from what I recall. With only 1.5% of patients having mild to moderate AE, it is a pretty compelling proposition. Lets get the refractory approval and then see where we go from there. GLTA beech
Comment by
loveshackdave on Jul 14, 2015 3:08pm
Not to mention the potential for off label use due to the BCG shortage.
Comment by
DryBones on Jul 14, 2015 10:23pm
and MCNA for high tea too.