JM2C, the portion of your post that is re-posted below has been stated in a number of previous SEC filings from ADVR.
<<In the new IND, AVR presently intends, among other things, (i) to establish that the proposed formulation of Reticulose is the same as the formulation of Reticulose referenced in cited publications; (ii) to include relevant information on the chemistry, laboratory and animal controls to assure the integrity of the dosage form; (iii) to include safety information for the initial study proposed to be conducted on humans; (iv) to include information assuring the proper identification, quality, purity and strength of Reticulose and a description of the physical, chemical and microbiological characteristics of Reticulose; and (iv) [v] to submit data supporting in vitro anti-HIV activity, or other criterion for a biological response modifier.>>
Information on all these items, i.e., (i) to (v), has been available for ADVR to provide to the FDA for quite some time now . Why is it that they have been so slow in submitting the IND? Could it be that there is something wrong with their data? Since it has taken so long could it be that it is humanly impossible to satisfy the FDA or that they can not or do not [for some reason] want to do so? Further, wouldn't it be nice if Dr. Hirschman could publicly explain the difficulty he is having in getting this information to the FDA? [not that we could do anything about it]
IMHO, there is has been enough scientific evidence and anecdotal information gathered about Reticulose over the past 60-years for the FDA to stop exercising its political power and instead exercise some concern for the afflicted that could benefit from Reticulose. Of course, I understand that if you have the money and the need [doctor's prescription], you can obtain Reticulose for compassionate reasons. |
