NRIFF.pk: Nuvo Research (NRIFF.pk) and partner Covidien (COV) announced that they have received notice that the FDA will now render a decision regarding Pennsaid approval in November, vice the expected August 5th date.
The delay, according to a joint press release, stated that the delay is due to the fact that Nuvo had provided the FDA with supplemental information since the initial filing which the Agency then determined to be a major amendment - hence needing the additional review time.
VFC's Take: The FDA has been behind schedule for quite some time now, probably due to a turnover of staff due to the most recent Presidential elections and associated changes in key personnel; so the 'extra review time' theory is probably just a cover to let them catch up a bit.
That being said, I like the fact that we can now buy the stock for a lower price.
I'm still positive on eventual Pennsaid approval, but it makes me feel a lot more comfortable buying this speculative 'FDA buy' now for nearly 40% less than where it traded last week.
NRIFF is still flying below the radar, in my opinion, so I'll accumulate a few shares in the low twenty cent range in anticipation of the new decision day.
Disclosure: VFC is long NRIFF.
TTNP & VNDA: With Fanapt news due at any time, the stocks of both Titan and Vanda Pharmaceuticals (TTNP & VNDA, repsectively) deserve to mentioned in the same breath.
Both stocks have traded down over the past couple of weeks in activity which I speculated was due to the MMs taking out stop-loss orders, and both traded up on Wednesday morning - moreso VNDA than TTNP.
I still call TTNP the better play between the two based on the fact that Titan will rake in royalties at no expense to the company and because I believe that TTNP, while still trading on the pinks, has not yet traded at it's full speculative value based on the potential of Fanapt and Probuphine.
For those that are just now looking to get in, I would prefer a buy of TTNP at around $1.50 than a buy of VNDA at around $16. That's just my opinion.
With Fanapt due to be launched in the fourth quarter, news of a partnership or buyout should materialize pretty soon.
Already huge winners this year, there may be more to come.
Disclosure: VFC is long TTNP and has no positions in VNDA.
EPCT: Shares of Epicept (EPCT) enjoyed an early-Wednesday 13% spike in price after the company announced that they have filed an NDA for Ceplene in Canada.
Due to previous drops into the thirty cent range and spikes to near ninety cents that I've traded, I'm playing with house money with EPCT so I am going to continue holding in anticipation of Azixa news.
That being said, I wouldn't blame anyone who is growing impatient with the stock to sell a portion of their position into this spike. It's better to realize some profits while you can because this stock does have a solid history of not being able to maintain a spike.
I've previously stated that I have written Ceplene off and am awaiting news on Azixa. That being the case, I have little interest in the Canada filing for Ceplene because of the fact that the company already has an approval in Europe but has failed to bring the drug to market. If they can't do that in Europe, why should we believe they can do it Canada?
There's still some potential with EPCT, but if you're not in now, don't buy on this spike. If they do release some good news this week then it's fine if you miss the boat on this one, you can buy on any dips later. However, it's likely that you'll be able to buy in later this week or next for a lower price.
Do keep in mind, however, there is a lot of potential in Azixa. If the next PR regarding that treatment is positive, we could double from these prices overnight.
Disclosure: VFC is long EPCT.