randychub,
Glad you asked. I have revised this so many times but here goes.
I for one am disappointed at the long silence.
Momenta has not seen fit to give any kind of an update to the shareholders. I don’t consider them their attending a Cowan conference the same an an update to shareholders after our shock loss. PFE and Sandoz have been quiet likewise.
If they can’t give us an update yet, say so and give us an idea when they can.
I still want to know when they first became aware of the problems. June of last year or when? It is going to come out sooner or later.
The full FDA letter is out there and I am not as optimistic things can be corrected so fast with a fast FDA approval. We don’t have Momenta’s input on their feeling yet. Surely they have had numerous discussions with PFE and Sandoz by now.
Per the FDA letter,
"These repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate.” and ''You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured, conform to FDA requirements.” Have they done this since June? Don’t know yet. Don’t know how far along they are yet. Bringing people into one site for a quick fix doesn’t sound like a correction of a global problem that will get the FDA approval. I guess they
could give piecemeal approval but, it doesn’t sound like they are after that kind of approval.
Did we not have some kind of cooperation deal with WuXi for potential drug manufacture not too long ago. I just could not find the PR. If I remember right they even opened an office in Cambridge to be close to Momenta. I am aware they were taken private.
I see they opened a plant in PA not long ago. They were building a new plant in Shanghai. The PA plant appears to be in compliance right now as well as the one in Shanghai.
It would seem that Momenta needs to assure with the manufacture or manufactures, in the future, that there has to be a back up system in place should this problem arise again. It is called Risk Management. What if the Pfizer plant has a fire or a tornado or another warning letter. Will we have to wait months for repairs, with major losses, before they can produce our drug again?
Not acceptable. Momenta should consider adding a risk manger if they don’t have one or hire a risk management firm to identify the companies potential risks. The Risk Manager should make sure their are back up plants in place with FDA approved plants that can take over on short notice. Just my thoughts. I don’t want to be going through this ever again. Momenta just develops the drugs so they have to make sure they are protected from this kind of exposure in the future.
Sandoz and Pfizer as big as they are, should have had these contingency plans in place. A risk manager could have made sure those plans were in place or have indemnity agreements should they not be in place.
Not a I’m sorry to the Momenta shareholders by either Sandoz or Pfizer to this point.
Boing X 2
