InvestorsHub Logo
Followers 0
Posts 484
Boards Moderated 0
Alias Born 10/10/2014

Re: davidal66 post# 923

Wednesday, 05/17/2017 12:55:36 PM

Wednesday, May 17, 2017 12:55:36 PM

Post# of 2099
davidal66 ... since the company has been through a SPA with rgbm, I think they know the pros and cons about doing it. I suspect they have more confidence in the ovarian results and therefore, need less assurances from the FDA. Not doing a SPA also cuts down on time and costs.

This site sums it up well:
"However, the SPA process can often take several rounds of FDA review before agreement is reached and the FDA may require a more robust trial design than what would have otherwise been considered adequate, which could result in unnecessary delays and increased costs. As with all aspects of drug development, a sponsor should carefully weigh their priorities before entering into an SPA agreement with the FDA."
http://camargopharma.com/2017/04/special-protocol-assessment-important-drug-development-program/
Volume:
Day Range:
Bid:
Ask:
Last Trade Time:
Total Trades:
  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y
Recent VBLT News