To: GrandPohba who wrote (2801 ) 1/19/1998 3:13:00 AM From: Afaq Sarwar Read Replies (2) | Respond to of 3906
GrandPohba, You have stated in your post: <Did you know that they have known all along their product did not require refrigeration?.> Your statement is correct. But there is a big difference between what was known by the company for some time, and what was contained in the news release. The following excerpt is from that news release: <Medhat Gorgy, president of Pyramid Labs stated: ''The stability study data for Harvard Scientific's lyophilized liposomal product confirms that the product is stable at room temperature for a minimum of 6-months."> First of all the word "confirm" should be noted. One can only confirm some thing that is already known. So the news clearly implies that this capability of the product was known. But apparently this knowledge was not based on rigorous scientific testing that would be acceptable to the FDA. I think the stability testing was done at least partially for this reason. Any time you subject some thing to a test, there is always the possibility and risk of a unpleasant surprise. In this case, the result turned out to be very promising. That has to be considered a positive news. Consider the typical. process of a new drug approval. No company would spend millions of dollars to go through clinical trials to get the FDA approval, if it did not knew or believed that the approval will be likely. Once the clinical trials are successfully completed, the likely hood of approval become even more evident. Then NDA is filed. At that moment, no matter what the company had known or believed about their product, there is no guaranty that it will be approved by the FDA. So when the news of the approval is announced very proudly by the company, no one discredits the news by stating that the company had all along known or felt that it will be approved, so what is the big deal. Afaq Sarwar