The blood platelets are probably the topic.
Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need; Public Hearing
The Food and Drug Administration (FDA) is announcing a public hearing to obtain input on a potential new pathway to expedite the development of drugs, including biological products, for serious or life-threatening conditions that would address an unmet medical need. The drug’s safety and effectiveness would be studied in a smaller subpopulation of patients with more serious manifestations of a condition. Such a pathway could involve smaller and more rapid clinical trials than would occur if the drug were studied in a broader group of patients with a wide range of clinical manifestations. The labeling of drugs approved using this pathway would make clear that the drug is narrowly indicated for use in limited, well-defined subpopulations in which the drug’s benefits have been shown to outweigh its risks. The purpose of the public hearing is to obtain information and comments from the public on the need for and feasibility of this pathway and its potential advantages and disadvantages.
Date: Februrary 4-5, 2013
Time: 9:00 a.m. to 4:00 p.m.
Location: FDA White Oak Campus
10903 New Hampshire Avenue, Bldg. 31 Rm. 1503
Silver Spring, Maryland 20993
Federal Register Notice1
All meeting attendees must enter through Building 1 on the FDA White Oak Campus. Parking is available in the Southeast surface lot and a shuttle bus will be available to bring attendees from the lot to Building 1. Please see Directions/Transportation/Parking/Hotels for the FDA White Oak Campus (PDF - 115KB)2 for directions and further details about transportation and lodging. Map of White Oak Visitor Parking (PDF - 105KB)3
Webcast of Meeting
For those unable to attend in person, the meeting will also be shown via webcast. Watch the webcast on February 4th and 5th from 9:00 am to 4:00 pm. Requirements and instructions for accessing the webcast are below. Please be sure to download the most up-to-date version of Flash Player.
Sentiment: Strong Buy
Whatever "Karen" believes, ACTC certainly will be a beneficiary of the decision that will come out of this FDA meeting!! The retinal trials will be expedited and the treatment would be accepted for at least limited clinical applications. I have no doubt about it. Stay tuned!
What are you smoking? This public meeting has zero to do with ACTC and their new, proposed IND application, that has yet to be submitted. They will meet with the FDA, privately, to discuss the details of submission, and what the FDA is looking for in the application. I suspect this is why the IND has not yet been filed.
Karen, I have to hand it to you, you have here totally destroyed the observation of dsroyal91 on the FDA Meeting. And even though I thought 91 was totally wrong I was very impressed momentarily by your post until I realized I needed also to be critical of myself for not considering the possibility you are busy here under multiple IDs setting up straw men you can then bash the he|| out of. Then I discovered you both came here around the same time, 91 a little bit later, which makes that possibility somewhat more likely. Still, I say to you, give us a great show, Karen, and continue to bash the he|| out of those straw men, wherever the he|| they are coming from.
Sentiment: Strong Buy