Soligenix Inc (SNGX)

[ragsto]

Am I understanding this correctly?

After the AC vote there were discussions on the trial designs as to the endpoints that were placed on the trials. The panel suggested that if the first 10 days were not taken into consideration and the 50 day endpoint was pushed out to 80 days and the 200 day mortality stayed that both trials would of met their endpoints.
Consider the above with the fact that there was no standard in the beginning to calculate endpoints to begin with when starting the trials.
Then in the meeting which took place in June it was stated in the July press release that it was the FDA who suggested and asked for data referring to the 2 trials to be submitted differently and not the company. In the same press release only 2 options were mentioned, 1 being approval or 2 being approval with conditions. Rejection was not even brought up.
Also discussed after the AC meeting was that in the last 20 years there were 15 drugs submitted for this condition and that only 5 made to a decision process, and out of the 5 orBEC was at the front of the pack (I believe I recall reading it that way).
Could it be that the FDA does indeed realize that orBEC is the right treatment for the condition verses what is existing now as the standard of treatment "corn oil", and is making the path forward for approval by asking for the revised data?
Does the FDA realizes that the treatment now and what has been attempted over the last 20 years is actually sub-standard to what orBEC has to offer? And just how long in the future will it be that anything else could be considered for treatment? Is it not best to error in favor of the patient when safety is not the issue.

Is that why the FDA requested the additional data?

Does anyone else have any other reasoning or comment?

I still favor approval as being 80% or Better.