http://www.avibio.com/news_detail.php?newsId=0080

 

AVI sent the GLP package for AVI-4658 IND to FDA. The answer is expected 30 days from the file date. As soon as the IND is open the trial can start, however when asked about start date the answer was not clear... they would like to see the results from the UK study 28 before the start, those will be available Q3 2010.

 

 

 

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Thanks Ofelia!!! This is great!!
I do not know what to say Cheryl...they lost a lot of money since last year, he presented 7 MM or more lost...I think they really need a partner to start a large trial. They might be ok if it's a small one site, but multi-sites longer with many boys...not too sure about that. You should listen to the call when they post it and let me know what you think.
I just read their financial report and I see what you mean Ofelia and I was thinking the same thing. I would think that they are already looking for investors or partners. Just have to stay positive that things will fall into place. Did you see the comment though that they made for Exon 50? Something about needing to decide if continuing it was warranted.

I got it in a google alert and deleted it here at work but I can post it when I get home.

Ofelia Marin said:
I do not know what to say Cheryl...they lost a lot of money since last year, he presented 7 MM or more lost...I think they really need a partner to start a large trial. They might be ok if it's a small one site, but multi-sites longer with many boys...not too sure about that. You should listen to the call when they post it and let me know what you think.
Yes, about AVI-5038, they need to look at all pre-clinical data before making a decision about continuing development.

Jacobs Mommom said:
I just read their financial report and I see what you mean Ofelia and I was thinking the same thing. I would think that they are already looking for investors or partners. Just have to stay positive that things will fall into place. Did you see the comment though that they made for Exon 50? Something about needing to decide if continuing it was warranted.

I got it in a google alert and deleted it here at work but I can post it when I get home.

Ofelia Marin said:
I do not know what to say Cheryl...they lost a lot of money since last year, he presented 7 MM or more lost...I think they really need a partner to start a large trial. They might be ok if it's a small one site, but multi-sites longer with many boys...not too sure about that. You should listen to the call when they post it and let me know what you think.
Yes, financial issues, but they have the chemestry and most likely will (or have already?) find deeper pockets to continue. It happened with Prosensa while we watched & worried. Even if AVI abandons their Duchenne pipeline somebody else will want it. Currently, as it is unfinished, their recipe has monetary value. Can't really see it falling off the map at this point. But if it does, we still have Prosensa, we still have knowledge the chemestry is there and possibly, if necessary, we can help it get into good hands. I have faith it will get here. Hopefully soon!
I agree. They mentioned that they continue to have discussions with interested parties.

cheryl cliff said:
Yes, financial issues, but they have the chemestry and most likely will (or have already?) find deeper pockets to continue. It happened with Prosensa while we watched & worried. Even if AVI abandons their Duchenne pipeline somebody else will want it. Currently, as it is unfinished, their recipe has monetary value. Can't really see it falling off the map at this point. But if it does, we still have Prosensa, we still have knowledge the chemestry is there and possibly, if necessary, we can help it get into good hands. I have faith it will get here. Hopefully soon!
This is an interesting presentation: http://www.avibio.com/events.php

Rodman & Renshaw 6th Annual Global Healthcare Conference

They also have slides... It's so impressive to see that one patient who responded so well 2 mg/kg...

When asked the question about the competition the CEO said that their understanding is that Prosensa is not increasing the dose level due to possible toxicity... Of course, he pointed out that they have clearance to go up to 100 mg/kg and are now only at 20 mg/kg. The biopsy data from the high dose groups should be presented during Q2...not much more to wait at this point.

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