At this point, with the PDUFA date just a few weeks away, is the fact that we have not heard about a delay a positive? How long prior to the decision do you think the FDA will decide they need more time to revisit the REMS?
I think if we dont hear of a delay within the next 6 trading days... next Friday, it is very good news. If it is a "challenge" to get the REMS done by April 30th, it wont be for May 30th. Further, the FDA wants some good PR and getting Prob on the market is good for society in terms of drug abuse. I am not expecting any delays but with the FDA and biotechs, never say never.
I think the REMS question is a very good one. Let's see what happened to another company that received a REMS delay after a very positive AdCom vote.
On April 4, 2012 Vivus Inc. (VVUS) submitted new data to the FDA regarding their REMS plan. In after hours on April 9, 2012 the FDA notified Vivus that they would delay REMS approval by 3-months. The closing price for VVUS on April 9, 2012 was $22.92, and the closing price the next day, Apirl 10, was $21.56 per share. That is a drop of 6 percent. Significant, yes, of course, but it is not the end of the story.
Eight trading days later the pps closed at $22.95, three trading days after that the pps hit $24.49, and two days after that the pps hit $26.75 per share. Note, after dropping 6 percent immediately after the REMS delay the price per share rose $5.19 per share, or 24 percent.
Did you notice something else? VVUS submitted their REMS plan on April 4th and received a delay notification from the FDA on April 9th. There is a weekend between those two dates. The point being the FDA does not need a lot of time to determine whether or not they need a 3-month extension! We submitted our new REMS in mid March. The FDA has 1 month and 22 days to review and approve the REMS before our April 30, 2013 PDUFA date.
Prediction: No REMS delay, and a 24% pps increase if we receive one! Being on the sidelines could hurt.
Sentiment: Strong Buy
Thanks for the comparison analysis. I certainly do not expect a long delay (more than 2 weeks); they must be close enough to believe they can get it done on time. But there could be a short delay, announced at the last minute, if they don't quite make it. I think a short delay based on REMS only will drive the SP over 2 quickly, and perhaps higher as it gets close to approval. Getting to 3 or more will probably not happen until Braeburn's launch plan is provided. There will be a lot of interest when approval is given; but many "bloggers and other guru's" will try to bad mouth the potential sales until they get their share of TTNP; then they will write just as forcibly that it will become the "gold standard" in opiate addiction treatment.
Yes, no news is good news everyday that goes by, but a delay could still be announced up through April 30th. By Now, one would think that the FDA would have an idea if they needed more time to finalize a REMs - but only time will tell. Have to wait . . . . . . Ask again next Friday.
Sentiment: Strong Buy
I would tend to think the FDA thrives on delays and CRL's, yes they do there job to an extent of some pretty hardcore questions and research before drugs can go to the market, hence thats why they are the FDA. But as I said its much easier to delay and CRL because thats how they make there money. Always have companies comming back for more. It is good and bad, depends how you look at which side of the picture. FDA quoted it will be a challenge to resolve REMS. I find the word Challenge as a way to throw people off, or maybe im looking to deep into the word. Does the FDA like challenges? Is it easier to say no than yes? Can I have a loan for a 50,000 car yet my income is only $2000 month and I have a negative debt ratio to income. More is comming out than going in.
This is all my opinion... I dont know the outcome, I know Titan works hard along with FDA.
Yet there is always doubt... APPA failed, ZGNX... Delayed... Im sure more to come. Its hard for a player to swing a homerun during the first time up batting no matter how good the team is. Its all chance and luck. Lets not forget about luck and failure in our Brokerage accounts!!!!!! Thats REAL!!!!!