News Focus
News Focus
Post# of 257262
Next 10
Followers 21
Posts 1902
Boards Moderated 0
Alias Born 06/06/2006

Re: linhdtu post# 185661

Thursday, 01/08/2015 8:56:47 AM

Thursday, January 08, 2015 8:56:47 AM

Post# of 257262
HALO - update

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.

There is a HALO board on invhub with more info

Trade Smarter with Thousands

Leverage decades of market experience shared openly.

Join Now