That is true, but it is taking the 505(b)(2) pathway (almost like a generic) and as such is substantially easier and safer.
This means they are able to leverage the known data on Melphalan as part of the submission. The PK/PD studies are trivial. And the CE technology has been used on many approved drugs, so that should be no issue.
Nothing is ever certain in this game, but this is a fairly safe bet.
Assuming clinicatrials.gov is correct (which it usually is for recruitment status) they started enrolling the NSCLC P2 trial 5/13 and stopped 2/14. That is not very long.
Before they could start enrolling the full 2B (200 randomized patients) they would have had to enroll the 27 patients in the 2A portion, treat them and get data. That sounds like a year or so easily.
I would find it difficult to believe that they ran the 2A portion, then recruited 200 more patients all in 9 months.
So yeah, sounds like the 2B was never launched.
Do have that billary trial FWIW.
I have no respect for Raj's CEO style.
I also have no respect for your racist attitude.
He is obviously talking about the CE-Melphalan aproval decision, not an NDA submission. The PDUFA data is this Friday.
Not a huge action, but certainly could be a tradable event if that was the reason for yek's question.
The FDA does not release the news (well, they will post an approval a couple days later).
The FDA will inform the company confidentially durring normal business hours, so very likely after the markets open. SPPI could release during the day (likely with a brief halt for new). Or they could wait till EOD.
One has to assume that SPPI failed to produce a sufficient package on what should have been a fairly straightforward NDA. Proven drug moa in the indicatoin, proven re-formulation technology.
Perhaps the FDA tightened up on some issue unexpectedly, but far more likely SPPI was deficient in a way that a competant organisation would have avoided.
Hopefully just a minor issue that can get a reasonable quick submission and 6(?) months action date. Hopefully not a 2 year animal cancer study or such.
How does somebody beat out somebody else by seconds on a 3 year old story?
I will reply to both you and jk at the same time.
Saying "these companies" really misses an important point. Small cap dev stage bios can be divided into 3 groups. Complete scams, crapshoots and those are risky.
Simply separating the scams from the rest helps a for an investor. Almost impossible to short most of the true scams though, and the synthetic shorts are expensive.
Separating the crapshoots from the decent (but still very risky) companies can make this a very good casino. Difficult though.
In this case though, TRVN clearly took a big step up that ladder. It is truly a more valuable company today that last week.
To simply say "these companies" misses the point.
BTW, I do think almost all these moves are initially overplayed. Even on solid legit good news there will a pop followed by some retrace. But that is a fast swing trade issue, and not what both of you are saying.
I often see selling naked calls as the best way to play the dark side. Put the ask up and hope somebody takes it.
For the record, I am long TRVN. I did sell about 40% on the move, as I always do.
clinicaltrials,gov says this month for the primary results to be in (that does not always mean released though).
CNAT says Q3
That would imply this week or early next week.
Note that unlike some trials where this is an estimate, CNAT knew exactly when the final data point would be available once the last patient enrolled. They updated these times a few months ago (after enrollment complete), so they should be accurate. At worst a fews days into Oct.
A) Taxes. Neither pay any, but DL has to account foe them as losses because they have their credits on the books as assets (they reversed the writeoff 2 years ago). AA does not account for them as losses as their credits are still written off (they will likely revese this in a few Q). That was a difference of $860M in Q3
B) DL took a huge hit on fuel hedges in Q4/Q1 when the price dropped (the other airlines were not as heavily hedged). Right or wrong the market tends to discount these one time "oops".
They said it is not clinical (which means the FDA is not claiming the trial was insufficient).
But that still leaves manufacturing and pre-clinical.
Manufacturing (CMC) is likely a minor issue. 3-6 months.
Pre-clinical could imply more rat-cancer data which is not a huge issue, but does certainly take time..
BTW, SPPI could most certainly release details and they did not. I would not be a buyer right now.
They completed enrollment late August so the updated primary date is not unexpected. Just a tweak to a previous estimate.
That last follow-up date looks odd, and I would not be surprised if it is simply a mistake. The primary and most all secondaries show the estimated date as 26 months past first patient (which is Sep) but the OS secondary is 5 months after that. Additionally, they almost always want to follow every patient for some period of time for AEs.
Mistakes on this site are not uncommon, and the estimated dates can be near random at times.
Would really be nice to hear a stat sig result in a couple months (as a P3, it can take a while to verify the dataset before analysis).
It is designed for all moderate to severe post op pain.
The reason why the 2 trials used bunions and tummy tucks was just to get a consistent set of patients to compare across arms.
And yes, the entirety of post-op pain is a quite large market.
Spitting out "pump dump" when you have not the slightest clue what the product/market is shows you are just one of those clown trolls who come around on sudden stock moves.
Activis / Allergan / Forest Labs / Watson are all the same thing now.
They are in for the acute heart failure drug. Will likely know this winter/spring if that is a go for further trials (which would imply milestones ... )
There are very few real shorts on a board such as this. And there are even less who are trying to convince people to sell.
The vast majority of "strong sells" are simply trolls. Likely just message board kiddies who get their kicks by these type posts.
Shorting this space as an individual is a very tricky game. I was doing a good bit of such in the 2000 tech bubble. Despite a market that was IMO even more overvalued, I almost got my #$%$ handed to me twice (both times I was dodging a margin call when I had a plus cash position a short time earlier).
One could be short a package of 10 stocks that go to zero one year later, but be out of the game before that happens.
And why would that be?
That another HIF agent works should not be surprising to anybody. So far, it is unclear if they are just a "me too" that is a few years back on the development timeline.
It is simply impossible that ABKA can run the P3 trials (probably N 5000) w/o a partner, so we shall shortly see how BP sees this playing out.
M Fool is 100% worthless on dev stage bios (maybe they have some value on companies that can be valued from financials alone, don't know). And they can be equally off base either pro or con.
There is no takeover in discussion. That is obvious, as they would have not diluted their own shares if that was the case.
The pop back is likely just a recover from the pre financing selloff. All kind of confusing with the timeline so compressed, but the trial news really was good.
I have serious doubts that the Fool can move a stock.
TRVN's pain drug is (or hopes to be) a better opioid. It could well replace a good chunk of the morphine market, but is still more or less the same.