Vertex Update

[Magnum]

Spoke to my contact at Vertex today. They are still compiling all data for the NDA (New Drug Application) of Telaprivir. This means they are hopeful all data will be submitted to the FDA before the end of the year. Unfortunately, this means more waiting.

However, once they do present the final data, there will be a Fast-Track priority for the FDA to approve or not approve the drug. Once all the data is in the hands of the FDA scrutinizers, they have to approve or disapprove within 6 months. A press release will be done by Vertex when the NDA is finally submitted.

As for VX-222, they are in clinical trials 1-2, which means they are near the end of trial 1 and moving into trial 2. This drug is supposed to eliminate Interferon and Ribavirin when combined with Telaprivir. Stay tuned...

Magnum

[willing]

thanks for the update. This reminds me a bit of those road backups, when, after hours of crawling along, you finally come upon a large group of trucks, front-loaders, foremen, heavy-equipment operators and OSHA inspectors all watching two guys patching a crack in  the sidewalk. How much f**ing time does it take to  submit the NDA? Didn't they have 48+w to write the boilerplate and format their excel sheets ? and Merck hasn't even started yet...

[spectda]

Boceprevir and telaprevir are not effective against g3. There is little or no change in success rates from soc.

[GoofyDad]

Does the new stuff target the non-1 genotypes?

[nygirl7]

In addition to telaprevir, Vertex is also developing VX-813, VX-985, VX-222, and VX-759 for the treatment of HCV infection. "

They've been very busy trying to get rid of crappy interferon and riba it would see even though I'm not sure what all the 'other' numbers are all about as the only one I heard about was 222.  

Still hopeful it's coming soon!

[FlGuy]

I wonder, when TVR is available for the masses, if Vertex will also recommend which brand of peg-IFN should go along with the magic pills.