Biotech Values

[deut8-18]

if the data was good off the bat, you announce the data and that the trial was successful, then meet with the fda. Since they must have had protocol violators that made the results miss the endpoint, before announcing the data, they met with the fda so they could put out press releases that the nda will eventually be filed because they will have several meetings with the fda.

at each meeting the fda will say do not file the data, it is crap but you will keep playing with the data and having more meetings, extending the defeat until you can sell your stock.
I have never seen a press release like this where the company met with the fda before announcing their data. why didn't they announce the data as soon as they had it, if it met the endpoints--drbio45

I believe that you haven't kept up with Neoprobe's story since they are a small co. and very much off the radar. The original trial was to do the Breast and Melanoma trial as phase llla then a Head and Neck squamous cell trial as phaselllb. They met the endpoints on the B&M and at the conferences Bupp has presented at recently has stated the the Head and Neck trials have, "NO misses to date" and "No negative surprises." Any other info can be found at:
http://advancedduediligence.blogspot.com/

I believe the meetings are to get approval for Breast and Melanoma designation prior to completing the H&N trial and then after completing the H&N they will proceed with filing for Sentential designation.

The cc should shed more light but I believe it is all good.

Deut 8:18

Deut 8:18