Posted On: 09/24/2013 10:05:41 PM
Post# of 5066
Re: patientgal #3245
So glad to be here and relieved to see you as the moderator on a board with REAL resources, data, and discussion about BMSN. I have read the past few days of posts and feel very up to speed on the speculation and educated insight. And thank you, patient-gal, for all that dang hard work!
I had talked to a woman a few weeks back that now works for a private bio and was once employed by avi now srpt. We talked about BMSN and i asked her what things might the FDA be interested in (or hung-up on) even with a great application. One thing she mentioned was the location of where the drug mixes with patient's bio. She asked me if ever the patient's fat (or whatever is extracted) will be taken physically from that lab or building to another location and then physically returned to that location. I could not answer. But she said this movement in trials causes FDA to pause and ask more questions. What are your thoughts? I hope this question and statement is clear. I apologize for my lack of understanding in it.
I had talked to a woman a few weeks back that now works for a private bio and was once employed by avi now srpt. We talked about BMSN and i asked her what things might the FDA be interested in (or hung-up on) even with a great application. One thing she mentioned was the location of where the drug mixes with patient's bio. She asked me if ever the patient's fat (or whatever is extracted) will be taken physically from that lab or building to another location and then physically returned to that location. I could not answer. But she said this movement in trials causes FDA to pause and ask more questions. What are your thoughts? I hope this question and statement is clear. I apologize for my lack of understanding in it.
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