Thursday, October 17, 2013 9:34:47 PM
Last year we had salmon for breakfast. This year we didn't have salmon or even fruit juice. I was really looking forward to some salmon on my way there.
Asked Dr Garnik before the meeting if we were applying for BTD. His answer blew me away. He said that BTD doesn't mean anything and that it will not speed things up. He said that FDA is a bureauracy and they take their time and just feeding them more data as time goes by is the best route. I didn't feel any enthusiasm in his words.
Asked johnson what is the status of getting to the bottom of dose switching. Him and steve basically said that they have explained everything to the FDA and that FDA is looking into it. Basically he said that it is out of our hands but we will try to get to the bottom of it.
Asked again if we are going to apply for BTD if not to speed up things (based on what garnik told me earlier) to give us recognition and steve said that they are looking into all options for recognition which includes applying for BTD
Asked them why can't we enroll 12 patients in the imaging study and whether we can give patient monetary incentives and steve said that patient icentives are a no no and that they are trying their best to enroll and that they are learning from what they have seen in the first three patients. Basically a none answer.
Asked why doesn't our name exist in any of the articles as far as immunotherapy and bavi goes and was told that your science needs to be peer reviewed before it can end up in the articles and that the recent I believe AACR peer review is going to get things going.
Asked if they have thoughts of giving away something like Bavi for viruses or imaging in order to get some cash to focus on Oncology and steve said that they are open to the idea.
With regards to the partnering, steve said that it is a long process and it is not a one meeting and close the deal thing. He said that companies take the data and take their time looking at it and do their own DD and come back later with more questions or they wait to see if their own drug works first
My take is the following
They have not applied for BTD or for some reason they are trying hard to hide it
After going through all that they have and finding out more about the potentials of Bavi they are not in a rush to partner unless they get their terms
Expect the company to attend a lot of conferences and try to put the word out
Somehow I kept hearing when the lawsuit is over in the side convesations that I heard. May be they cannot say much until end of november
I think they are really trying to make it work and felt that the event of the last september really hurt their feeling just like it hurt ours.
I hope that garnik was just having a bad day or frustrated from the FDA and not in it for the oder side. This could very well only be me and the wibes that I got.
I got the sense that the IR jockers (I forgot their names) are very rude
Well if something else comes to my mind I will post. I am going to go buy my own salmon
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