Tovaxin Open Label Extension Schedules

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Postby av8rgirl » Fri Aug 08, 2008 9:19 am

JanethePain wrote:
flipflopper wrote:... I'm a little annoyed so this post is simply to vent. I won't mind any of this (and I will feel extremely lucky to be in this trial) if Tovaxin publishes great phase IIb results but today I'm a little annoyed!...


I try to keep my "grateful" face front and center, too, but I'm lately getting worried (as well as annoyed). I mean, sheesh, guys, we're probably less than a year from the start of Phase III. Phase III means a LOT of lab rats in the equation (I was once told "5000" or so). If Opexa is this (seemingly) overwhelmed with 150+ (our gang and the first batch with Our Very Own Tim) of us... can you imagine the snafus when they rev up for Phase III?!?!

Okay, that's enough fear-mongering for one afternoon. I need some medicinal Cheetos.


I wonder too Jane.

Cheetos? How about Double Chocolate Mocha.

I am getting ready for a nice vacation to Wales in less than a month....I have a lot of work to get done before I go, so will be busy and then a week after I get back, I go for redraw #3.

With all this heat, MS is starting to kick my butt again. It's been 3 months since my last exacerbation....I hope I am not back to the same 3-4 month interval I was on before I started the trial. I don't need this. This 90-day interval for re-draw I am sure is a cost saving measure for the company, but it is frustrating for those of us who are waiting to get into the extension study.

At the same time, I don't understand the long delays for procurement once you test positive. What are they thinking? Just venting...sorry....
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Postby Lars » Sun Aug 10, 2008 9:54 am

Apparently some things are changing with procurement protocol. It seems trouble with site locations has become an issue. Opexas required timing is not being met, thus procurement at trial sites (overseen by Opexa) seems to be where this is headed. At least that seems to be my destiny. Whatever works and speeds things up is welcome news. There seems to be to many Chefs in the procurement kitchen.
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Postby av8rgirl » Sun Aug 10, 2008 10:10 am

Lars wrote:Apparently some things are changing with procurement protocol. It seems trouble with site locations has become an issue. Opexas required timing is not being met, thus procurement at trial sites (overseen by Opexa) seems to be where this is headed. At least that seems to be my destiny. Whatever works and speeds things up is welcome news. There seems to be to many Chefs in the procurement kitchen.
Lars


When I had my first procurement, Opexa sent a tech out from Tennessee to draw my blood. It didn't take much coordination as far as I could tell. Site coordinator called me and told me when I had to be where (I am 450 miles from the site) and I was there. Very simple.

I am not understanding what the difficulty is this time with the procurement draws. Are they trying to coordinate drawing a bunch of people at the same time at one location to save money?

Are you saying that the procurement draw has been scheduled now?
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Postby Lars » Sun Aug 10, 2008 11:02 am

av8ergirl,
To the contrary, I think ultimately this will cost Opexa a lot more. Sending a tech to every clinical site to oversee draws can not be in Opexas best financial interest. My understanding is that Opexa requires Donor sites to handle certain blood results in 7 days and that at least in my collecton site, that can not be guarantee less than 30 days. Therefore Opexa is struggling and I believe frustrated, at Lifeblood and collection sites role in all this. My site coordinator who is wonderful, has not even been made aware of these changes so I think we are in the middle of a "change of protocol". To answer your question, no, I still don't have a date scheduled but honestly I am much happier at the prospect of going to my trial site than to Denver which is a much longer drive. I really think this is the way it should have been handled all along. I did do my phone interview with Shelby last week and that is when all this came to light.
Be Well,
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Postby av8rgirl » Sun Aug 10, 2008 11:16 am

I think you are correct, sending a tech out for each procurement draw would be expensive. On the other hand, having everyone wait so long for the draw is not in the best interests of the trial either and could potentially become very expensive.

Example: If a patient were to have an exacerbation for instance, wouldn't that delay the procurement draw? Be cause for a retest of the MRTCs? Then another delay if the test were to come back negative? On and on and on....

It would make sense to me that once the patient tests positive for MRTCs that the sooner the procurement draw is done, the better for everyone involved. But I am not in charge!

Change in protocol? That would be having a local company do the procurement draw? Under contract? Isn't that the way it was done in the beginning? I seem to remember something about that but the contract was over when I entered the trial. So, I cannot speak to that issue.

Bottomline, it all needs to get back on track and is there anything we as lab rats can do to push? Or do we just wait and keep quiet?

Just typing out loud, counting the days until my next retesting date! (and not making any more phone calls!)

Lars wrote:av8ergirl,
To the contrary, I think ultimately this will cost Opexa a lot more. Sending a tech to every clinical site to oversee draws can not be in Opexas best financial interest. My understanding is that Opexa requires Donor sites to handle certain blood results in 7 days and that at least in my collecton site, that can not be guarantee less than 30 days. Therefore Opexa is struggling and I believe frustrated, at Lifeblood and collection sites role in all this. My site coordinator who is wonderful, has not even been made aware of these changes so I think we are in the middle of a "change of protocol". To answer your question, no, I still don't have a date scheduled but honestly I am much happier at the prospect of going to my trial site than to Denver which is a much longer drive. I really think this is the way it should have been handled all along. I did do my phone interview with Shelby last week and that is when all this came to light.
Be Well,
Lars
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Postby JanethePain » Mon Aug 11, 2008 10:20 am

av8rgirl wrote:... I am getting ready for a nice vacation to Wales in less than a month...


Where in Wales? My best friend and I did our 40-crisis with a 23-day "event" in Great Britain during the off-season (you can see and do twice as much for half the price); put a bezillion miles on a rental car--I think we really got our fill of castles and battlefields and museums. :)

Wales stands out as a memory for me because that's where my friend wanted to check out as much ancient and medieval "celt-dom" as possible. Those burial chambers on Anglesey Island are really interesting--right in the middle of sheep farms and guarded by bulls--that was kinda scary--but interesting, anyway. :lol:
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Postby Lars » Mon Aug 11, 2008 1:01 pm

Update: O.K. my head hurts! I have been on the phone today with Scott at Lifeblood and he also has no knowledge of the "procurement realignment" and is processing me at the site in Denver. The big issue seems to be a virology panel that MUST be taken 7 days before or after the procurement, which I have no memory of a year ago For some reason that cannot happen at my procurement site but it can happen at my clinical trial site?????? So, I am going to Denver for procurement then to my trial site for virology. Opexa seems more than willing to send a Rep. to my trial site to do all of this but the timing can't happen quick enough for my trip this week. Did I mention to many Chefs in the kitchen? All I can recommend to everyone at this point is to get on the phone!
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Postby av8rgirl » Mon Aug 11, 2008 6:43 pm

LAND ROVER WORLD SHEEPDOG TRIALS 2008
Thursday 11th - Sunday 14th September 2008
Dinefwr Park, Llandeilo, Carmarthenshir

There are 3 of us going, me, my sister and my best friend. It's her idea, we are just tagging along for the fun! We fly into Manchester as the original site was just outside Manchester. After we bought our tickets, they changed the venue! Too late to change our tickets, and besides, there really isn't an airport closer. We are renting a car for the time we are there and going to have a ball! Staying 10 days. My friend's birthday is 9-10 and my sister's birthday is 9-11. (no I am not kidding!). She wanted to spend her birthday someplace other than a crisis site this year (she's a FEMA volunteer).

Looking forward to this...I get back just in time for my next re-draw appt!



JanethePain wrote:
av8rgirl wrote:... I am getting ready for a nice vacation to Wales in less than a month...


Where in Wales? My best friend and I did our 40-crisis with a 23-day "event" in Great Britain during the off-season (you can see and do twice as much for half the price); put a bezillion miles on a rental car--I think we really got our fill of castles and battlefields and museums. :)

Wales stands out as a memory for me because that's where my friend wanted to check out as much ancient and medieval "celt-dom" as possible. Those burial chambers on Anglesey Island are really interesting--right in the middle of sheep farms and guarded by bulls--that was kinda scary--but interesting, anyway. :lol:
Last edited by av8rgirl on Wed Sep 24, 2008 7:49 am, edited 1 time in total.
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Postby Lars » Mon Aug 11, 2008 8:07 pm

av8rgirl,
Have a GREAT vacation!
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Postby Aggie03 » Mon Aug 11, 2008 8:35 pm

Well I got the call today to set up a procurement. I am set for August 25th at my clinical site. They are also going to do the virology panel right then and there.
Hopefully it all works out.

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Postby Lyon » Tue Aug 12, 2008 12:39 pm

..
Last edited by Lyon on Wed Jun 22, 2011 3:28 pm, edited 1 time in total.
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Postby Lars » Tue Aug 12, 2008 2:15 pm

Final post on the "procurement issue". Scott has me set up for procurement at my original donor site in Denver this Thursday.
Aggie, good luck. We are now in a head to head race towards "injection day"!
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Postby Sweetyhide » Wed Aug 13, 2008 9:55 am

My 2nd injections are August 26th

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(luckily not there lol)
~Sweety
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Postby JanethePain » Wed Aug 13, 2008 12:14 pm

Sweetyhide wrote:My 2nd injections are August 26th

Image
(luckily not there lol)


I love your little guys but much more bragging about being on schedule and you just MIGHT get a surprise there! :o :lol:
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Postby Sweetyhide » Wed Aug 13, 2008 12:43 pm

JanethePain wrote:I love your little guys but much more bragging about being on schedule and you just MIGHT get a surprise there! :o :lol:


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