Replies to post #121159 on Biotech Values

[newtostocks23]

I'm going to give my opinion on this matter. Since the collapse of RIGS in the 1990's and under David Bupp's direction, they approached the FDA with the utmost caution. Before conducting their trials, they would meet with the FDA to discuss everything to death before proceeding. It drove long term investors crazy because everything took so long to develop. The approach to the trials neo3-05 and neo3-09 were not treated any different.

As Mark Pykett (CEO) explained in one of the latest CC's..

"The clinical trial design process was exhaughsted. Neoprobe consulted multiple clinical investigators on the design of the trial and continually engaged the FDA including extensive discussions on trial endpoint. The basic non inferiority design of neo3-05 and 09 trials was essentially identical between the 2 protocols. The FDA has reviewed the protocol design not once but twice and has reviewed results from one trial while offering recommendation and guidance on the second trial. That is why we are confident in the design, regulatory positioning, clinical value, and findings of lymphoseek clinical studies and what they mean to the agent and more importantly to the potential impact on patient care."

So in my opinion based on the facts presented, the trial is not flawed. I would like to know how the FDA can reject a drug for which they gave their guidance and recommandations in how the trails are to be conducted...

other quotes I've gathered from management: http://bit.ly/lDMrjd