Letter to Graeme Gave it a shot....
Hi, Graeme,
I am probably stating the obvious to you here. I hope you don't mind me voicing my thoughts. As far as I can see regarding the HC NOC/c application, I can see the following:
1. If we apply for 1st line use, we might have a problem because we don't have any data that compare Urocidin directly against BCG for its comparative effectiveness. We cannot know whether it is more effective or as effective as BCG in the 1st line patients.
2. On the other hand, Datas from P2 and P3A (and possibly P3B) show good efficacy from Urocidin in the refractory patient group. We can venture to imply that Urocidin will be at least as effective in the 1st line patients. Whether HC will accept this presumption is a big question.
3. However, we do have data that shows significantly superior safety factors and ease of handling. We can use the following rationals to convince HC for the 1st line approval:
a. Saving from cost of needing hospital and special treatment facility stay for the instillation as is needed in BCG. (Example: In 2006, Bladder Cancer has the 5th highest overall cost, estimated at $3.4B annually with $2.9B in direct treatment-related costs, and indirect costs of $184,762 to $461,907 pp.)
b. Elimination indirect cost of management of cross infection to by-standers which could add to the healthcare cost
c. Compliance....As you said in the CC. BCG has a low compliance rate. If patients do not carry through to complete of the full schedule of the treatment, we will not get the result intended. Thus, it is a total waste of treatment cost. I am sure the National Healthcare system would like to see its money spent on treatment that can yield results that it is designed and supposed to.
d. From the standpoint of compliance, one can also confer the assumption that even if BCG had higher efficacy than Urocidin, the higher compliance rate due to Urocidin's safety and ease of handling will make it more likely for patients to carry through to the completion of treatment. As such, it will most likely yield a higher overall response rate than BCG.
Even though the per dose cost of Urocidin in refractory patients can be significantly higher than the 1st line patients. I think the high number of 1st line users can compensate for some of the difference. Also, with a lower cost per dose, it is easier for the physicians to use it "off-label" for the refractory patients. In the u.S., the cost of "off label" use will most likely have to be borne by the patients.
At this point, the cash burn is a very big concern to us shareholders. We would like to see this burn to be eliminated as soon as possible to preserve the share value. I am sure you and your staff are working diligently to address this problem. I am hoping that you can work your magic and pull another rabbit out of the hat and "give this bus enough fuel to carry us to the end."
Best,
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