Well, that wasn't fun. I spoke to the company twice today. Still dealing with fog of war issues, so they/I may have a different view in a week or two. As I’m sure you heard on the call, the company believes the primary issues are CMC (e.g., manufacturing). During the BLA review, OTLK and the FDA had several mid/late cycle reviews. During these, there were some questions asked that the company answered and then there were some expected questions that were never asked. The company prepared data/reports for these expected questions. The hope is that these questions are the primary holdup. However, there is lack of clarity.
If issues are confined to CMC, then expect the Type A meeting in mid-October and a BLA resubmission in November. Could have approval summer 2024. High dose Eylea has CMC issues and was approved in 2/3 months. I'm using a longer timeline because I don't like to talk best case.
The last issue mentioned in the CRL was additional confirmatory evidence. The company is not sure what that means exactly and if it can be remedied without a trial. If it requires a trial, it should be small/short, to verify the large trial that showed strong significance. The company can initiate a small trial quickly (1 - 2 months) and run it/analyze data over about 4-6 months. If this is the case, all in assume BLA resubmission in summer 2024.
Capital is the last concern. They have $~35M debt maturing at year end. I know the lender and they will extend for a payment (their business model is not running or restructuring companies). The lender wants clarity from the Type A meeting to determine terms to extend. If this debt is extended, the company has funds though 2Q'24.
I asked if I should put a term sheet together for funds down here but was told no. Remember that 40% of the company is held by large insiders, one with board seats. They don’t want a raise down here.
