You are a sad man... coming here just to say you were right. I could take a two-sided position and come back and say I was right when I see it go my way too..
As the saying goes.. even a broken clock is right twice a day.
The FDA is allowing them to go through the approval process without proving durability having the previous data + the new data in hand (which still does not show long-term effectiveness). It would be extremely two-faced if the FDA gave them the go ahead knowing they had the same data they denied them previously, then deny them. They did not require the same efficacy standards when they allowed ProAmatine to be approved.
Also, the FDA guidance statement said this about CHTP's resubmission criteria:
The guidance suggests that "data strongly demonstrating a short-term clinical benefit (e.g., improvement in symptoms or ability to function) of droxidopa in patients with NOH would be adequate for approval, with a possible requirement to verify durable clinical benefit post-approval."
Nowhere did it say they were required to do so before approval. They are allowing short-term benefits as a pathway to approval.
"FDA also noted that the Company may be required to verify the durability of effect of Northera in a post-marketing study. Chelsea continues to work with the FDA on the design of such a study, which it intends to initiate in the fourth quarter of 2013. The study is expected to include short-term clinical endpoints should the Agency require an additional clinical trial for the approval of Northera."
FDA stated, “data strongly demonstrating a short-term clinical benefit (e.g., improvement in symptoms or ability to function) of Northera (droxidopa) in patients with NOH would be adequate for approval, with a possible requirement to verify durable clinical benefit post-approval.”
I agree. He is very clearly short-biased and releasing random info that favors his views at his convenience. What happened to all his positive bs about CHTP and his target of $10 from a month ago? Oh right, he dumped it for a small gain to get into another stock and now acts as if he has no interest in CHTP anymore.