Replies to post #753607 on NorthWest Biotherapeutics Inc (NWBO)

[Investor082]

Will you stop lying and posting on this board if the revenue in the first year is less than $15M? It won’t be a supply problem. It will be a demand issue due to no reimbursement support.

Eden will not be approved for commerical production for another 18 months. Take that to the bank!

[exwannabe]

Steady T, it's true that the UK accepted the tiny capability at Sawston for meeting initial commercial requirements.

Nonsense.

The MHRA has said that Advent follows GMP for commercial manufacturing in general, but nothing about any specific product which is a different approval. They have not said anything about DC-l specifically or any sort of demand.

I am glad you are already rich and can afford a Rolls, because investing is biotech is clearly not your strength.

[Steady_T]

We have differing understandings of the situation. FDA wants to see commercial production capability that it can inspect. We agree on that.
Where we have differing views is I don't think the FDA is concerned with capacity, you do.

It appears to me that the company understands its lack of capacity to service the US market if it were to be approved before EDEN as an approved production source so it has decided not to pursue the FDA BLA until it is in a position to service the expected demand. I think that decision is a function of the lack of money available so the company is not spending on things that will not provide a rapid return.

I hope that the company starts the FDA BLA process as soon as the UK approves with the expectation that EDEN will be approved by the time the FDA acts. Of course the company knows how far along the EDEN development is and when they expect it to be approved. Based on that knowledge they will apply to the FDA at the appropriate time.