Post by babaoriley on Aug 7, 2014 1:26:57 GMT -5
Did this already get posted here? If so, please delete this whole thing, if not, check it out:
Reply to query about Amphastar from MNKD
I just wrote to MNKD to inquire about yesterday's SEC filing and some of the concerns it raised. I received the following reply from Mr. Pfeffer. I am sharing to quell a few rumors here.
*****************************
"Let me tell me what I can.
Amphastar owns the facility that manufactured all the insulin used in our clinical trials to date supporting the Afrezza product approval. That is the only insulin source that is currently approved for use in the product. We can, and indeed plan to, add additional insulin sources, but these must be approved by the FDA, which will require clinical study in support of an application. There can be no certainly of any particular timing by the FDA, or that they will approve such hypothetical insulin at all. So a prudent company, if they were thinking of launching a product and thought it had a good chance of success, would want to be sure they have an ample supply of insulin immediately usable.
Note that this insulin has always been made in France. There has been no change.
Finally, we would not enter into such an agreement unless we were confident that we would be able to use it and that we would be able to pay for it.
Hope that helps."
I don't know if that helped Jonathan, but if his post is accurate, it helps me.
Reply to query about Amphastar from MNKD
I just wrote to MNKD to inquire about yesterday's SEC filing and some of the concerns it raised. I received the following reply from Mr. Pfeffer. I am sharing to quell a few rumors here.
*****************************
"Let me tell me what I can.
Amphastar owns the facility that manufactured all the insulin used in our clinical trials to date supporting the Afrezza product approval. That is the only insulin source that is currently approved for use in the product. We can, and indeed plan to, add additional insulin sources, but these must be approved by the FDA, which will require clinical study in support of an application. There can be no certainly of any particular timing by the FDA, or that they will approve such hypothetical insulin at all. So a prudent company, if they were thinking of launching a product and thought it had a good chance of success, would want to be sure they have an ample supply of insulin immediately usable.
Note that this insulin has always been made in France. There has been no change.
Finally, we would not enter into such an agreement unless we were confident that we would be able to use it and that we would be able to pay for it.
Hope that helps."
I don't know if that helped Jonathan, but if his post is accurate, it helps me.
