They actually havent been removed but there is a privacy code now. You can still go to her website but you have to be friends with her and given a security code to view the info on the clinical trial.
Probably because you are all talking about it so much and instead of keeping the results in the back of your mind and hoping for the best now they had to be removed. She was a strong girl who had both the patient and healthcare worker perspective. She wanted to give us all hope and now that hope is removed. I know it is exciting but we just need to follow stories without universally broadcasting them and then we will know what is going on.
If you keep reading through that original link to the forum at cysticfibrosis.com, there are two new pieces of good (or at least interesting) news.
First, there's a second person from the 809/770 trial who reports feeling much better. (The first I found was a comment on this blog entry: http://www.cfgirlseyeofthetiger.com/blog/2012/03/20/Halfway-through-.aspx) Here's a quote:
"Yes, I am feeling great! I was so hopeful going into the study. I knew I would not see results with 809 alone but still, I was disappointed and lost some hope while on 809 alone. I started the combo of 809 and 770 and by day 3, wow. No longer crawl out of my skin exhausted, much less cough and as time goes by, I am coughing up much less. Some coughs are just coughs, nothing to bring up! I dread going off the meds. I have no idea what my PFT's or sweat chloride levels are because the study is double blind."
Second, one of the posters on the forum says he's taking kalydeco off-label. I assumed that lots of people might want to use off-label kalydeco, but I didn't think anyone would be able to get their insurance to pay for it. If there is significant off-label use, that could vastly increase Vertex's kalydeco revenue.
First of all...holy cow, this is HUGE (potentially many prayers answered)...then two thoughts race through my pea brain...
First: The 'free talking' by patients leaves me excited yet curious and concerned. Anyone else feeling this way? Is this just a sign of the times? Seems like this kind of stuff could have positive/negative affect on publicly traded stocks. What's that phrase, "Loose lips sink ships?"
Second: This must be a very perplexing time for Vertex and the CFF. Obviously, if money isn't an issue...we'd want them run with all 3, so long as it doesn't slow down the SPEEDY clinical trial and approval of 661. Heck, why wouldn't Vertex patients get on 779/809 for a couple of years, offering near term benefits to CF patient then switch them over to 661 or 666/770 combination when 661 is/if approved? Money in the bank, right?
The thing is...money, IS an issue, and it always is. Trials are insanely expensive and making sure the FDA does their approval of 809 correctly is vital to a smooth approval process for 661. (Remember, these drugs are cheap to manufacture...we're not talking a protein...these are small molecules)
I believe it will all come down to how well 661 did on its own (especially) and in combination with 770. If the 661 #'s are thrilling (like Kalydeco for g551 mutation) 809 will likely be scrubbed. If the #'s are "okay" and 809 #'s are "okay with moderate SC improvement and some FEV gains, I bet they move towards 809 approval with 770 focusing on SC improvement if nothing else.
I think that girl was just trying to give everyone hope. If you read her blogs even before the trial started, she works in healthcare and has both point of views. She was trying to help those that feel it is hopeless! I dont think your saying loose lips sink ships is appropriate. She was like an angel, the light at the end of the tunnel. If it is all money based then shame on them. These CF patients want a future, want a life and how cruel of you to put someone down who was trying to help others. If you look now all the blogs have been removed probably because of our discussions here. Stop trying to analyze everything! You said the free speaking made you worry, well good job now we will know nothing!! Thanks!! Shame on you for thinking of publically traded stocks before people's well being!!
It will be an earth-shaking event if VX-661 works for the majority of 508del CFers as well as it appears to do for the [Katie] person. It is exciting to think about the possibility.
The phase IIb study of 809/770 combo is a blinded trial, and it would be very irresponsible for any [Vertex representative] to leak the results. No one is supposed to know who are taking the placebo and who are taking the higher doses of 809. However, it is possible that the [Vertex representatives] speculated about the fate of 809 at the time they spilled beans out of excitement in talking about unusually good results from VX-661 trial to the anxious CFers.
Yes, if 661 works that well, WOW. I've re-read that post probably a hundred time for the hope it builds. Interestingly, she is only on 661 and not the 661/770 combo. From some additional things I've read, it sounds like some double deltas have amazing results just from the potentiator or just the corrector. (There's quite a bit of "chatter" on the CF forums etc. re 508ers trying to do Kalydeco off label in the event they are one of the few who would benefit from 770 alone. Have you heard/read anything that supports the idea that 770 alone (or 809 alone) worked significantly for some 508ers, but not others???? Was that mentioned in discussion of initial results?
I completely concur with your comments re 809 and the supposed statements by Vertex. I think what is more likely is that some reps repeated what is already public, i.e., that whether 809 continues or not depends on 661 and possibly even they went a step further if 661 is working so well and said they are planning on moving with 661. And from there a little game of "operator" changed the actual statements.
Also fwiw another blogger who finished the 809/770 study mentioned they felt great after and now that they are off, back to baseline.
I'm torn between feeling optimistic for 661 and sad thinking 809 is not going to move forward, but then remember that Vertex's tone in last few presentations on 809 has definitely changed for the positive AND that you don't need alot of improvement to get approval in the CF arena, and with "free" (i.e. CFF) money funding, why not continue both. . . .It's going to be a long year waiting on the results. Would love others input if they have any insights.