RE:RE:RE:The plant checkpoints are obviously done:Good point, Stockbufoon. The question is has the pre BLA filing meeting taken place with the FDA? This is critical for the timing of the submission and also the announcement of the partnership deal. Hopefully Galbraith will give answers and insights on the 2019 results call due by the end of the month. Hopefully, guidance will remain the same that is the BLA will be refiled in Q2 and the partnership announced before the refiling or soon thereafter. I certainly hope the can is not kicked down the road again but who knows.
with Coronavirus shaking the world, it is sad that it is taking so long for Ryplazim to get approved. Many Covid patients are dying of acute respiratory disease - one of the applications that were going to be targeted following approval congenital deficiency. Hopefully the new partner will put some money into developing future applications of Ryplazim to respond to the health crisis facing the world today.’