I am new here, as I have seen many people post about this stock on forums of other biotech stocks that I am currently invested in. My main question is, how long until this company has its product approved by the FDA. I read the recent article today about the stock hitting targets and therefore receiving $, however, I am wondering if I should continue to watch this stock in the future, and buy on dips, or if there is likely to be major catalysts in the near term and I should try to create a position soon. Thanks for your help, I will continue to do my DD in the meantime.
Most drugs undergoing Phase III clinical trials can be marketed under FDA norms with proper recommendations and guidelines, but in case of any adverse effects being reported anywhere, the drugs need to be recalled immediately from the market.
While most pharmaceutical companies refrain from this practice, it is not abnormal to see many drugs undergoing Phase III clinical trials in the market
It is common practice that certain Phase III trials will continue while the regulatory submission is pending at the appropriate regulatory agency.
This allows patients to continue to receive possibly lifesaving drugs until the drug can be obtained by purchase. Other reasons for performing trials at this stage include attempts by the sponsor at "label expansion" (to show the drug works for additional types of patients/diseases beyond the original use for which the drug was approved for marketing), to obtain additional safety data, or to support marketing claims for the drug.
Studies in this phase are by some companies categorised as "Phase IIIB studies."
Everything regarding Urocidin is running very well so far. Officials at Endo have even said that if the next study group which will involve over 400 people goes well, they would anticapate FDA approval in mid to late 2011 with product launch in the first Q of 2012.
After several years Bioniche is finally going from govenment funded/research driven to proven research and with profits finally being realized. Quite a few irons in the fire right now. Buy and go long.