Much of the data published for study 202 who enrolled aprox 140 patients (prior to FDA halt) - results were very good such that they are talking about a FDA meeting for first quarter to initiate a phase III registration trial. Some have mentioned applying for breakthru status. This will be a global registration trial and they estimate expenditures at 125-145MM....not sure if this covers the expense of the whole trial.
Some of the data/posters will be release in January and some at a conference in April.
They will have the option of selling rights or partnering this out if they want to.
Very positive guidance on revenues/royalties of 85-100 million, possible Enhanze partnerships as the platform has been validated by Roche and Pfizer and recently Janssen signed up.
The surprise will be Hyqvia being marketed by Baxter - how well the ramp up is since it launched in November 2014.
(HALO)—BXLT CEO at GS webcast says HyQvia is “on track” for $1B in worldwide sales in 2020, acknowledging that the HyQvia price premium relative to ordinary IVIG won't play well in some countries. (3Q15 HyQvia sales were about $100M.)