If the Secretary approves an app, or issues a license for a drug designated under section 526 for a rare disease or condition, the Secretary may not approve another application under section 505(b) or issue another license under section 351 of the Public Health Service Act for such drug for such disease or condition for a person who is not the holder of such approved application or of such license until the expiration seven years from the date of the approval of the approved application or the issuance of the license. Section 505(c)(2) does not apply to the refusal to approve an application under the preceding sentence.
(b) If an application filed pursuant to section 505(b) is approved for a drug designated under section 526 for a rare disease or condition, or if a license is issued under section 351 of the Public Health Service Act for such a drug, the Secretary may, during the seven-year period beginning on the date of the application approval, or of the issuance of the license, approve another application under section 505(b) or issue a license under section 351 of the Public Health Service Act, for such drug for such disease or condition for a person who is not the holder of such approved application or of such license if---
(1) the Secretary finds, after providing the holder notice and opportunity for the submission of views, that in such period the holder of the approved application, of the certification, or of the license cannot assure the availability of sufficient quantities of the drug to meet the needs of persons with the disease or condition for which the drug was designated; or (2) such holder provides the Secretary in writing the consent of such holder for the approval of other applications, or the issuance of other licenses before the expiration of such seven-year period.
(2) such holder provides the Secretary in writing the consent of such holder for the approval of of other applications, or the issuance of other licenses before the exp. of 7 yrs.
It would be helpful if you would base your comments on true analysis vs. conjecture... next appropriately communicate your rationale. Until then no one will seriously consider your vitriolic posts.
Exactly.... I don't have time for those with a traders mindset who trade into SPPI on a daily basis,.. and change their sentiments like their underwear!
I'll buy more shares as soon as possible!
Yes... I don't recall the specifics... as I recall talked about the p-values of the individual trials, the p-value of the combined, FDA's agreement to combine, and I thought a trial launch in 2nd half of 2015.
"now have selected more than 80 sites... for PH III trial to start in Q2... company has the revenues to complete the trial... we don't need to raise any cash.... "
clean your ears out... apparently you are hard of hearing.... he seems very energetic... and impassioned... and I'm sure you'd be the last to recognize or acknowledge that.....
"..... *not* a topic to be decided in a court of law... it's protected by FDA orphan drug... "
stick that in your pipe and smoke it Shorties....
"Sandoz drug is not at **all** similar to Fusilev... not stable at room temperature, etc..." Raj
I would have expected more of an explanation,.. but it's to the point....
The impact is that Sandoz likely won't be producing competing products any time soon....
Expectantly, we'll hear something more at the upcoming earnings call....
I won't comment further on the after-market on Monday other than to say it was approx 2.7M shares traded around $5.00 - 5.40.
What I will comment is on Monday.... Expecting an 8k out, based on the comments of others.. this *may* give us better clarity to what happened, e.g. SPPI's interpretation for immediate and longer term impact... but then again, following SPPI habits.. it might be quite vague. If SPPI is still writing it... I'd guide them to provide investors with a candid assessment - based on what's known today.
Shifting our focus to the trading considerations... I will warn investors.. that if you're looking to Monday's trading to be the barometer of truth considering SPPI's, you might be mistaken... I'm personally expecting the institutional investors to try and establish the new trading range around $5 - $5.40,... simply because they can... Depending on how well or poorly worded the 8k is,.. may either restrict or aid 'tutes in their scheme.. To their credit,.. they have a history of SPPI being very poor in their communications and assessment of near-term outlooks... (at least that's my view)..
If you read Bio's view... he "contritely" states that a "34% hair cut would be appropriate for the short term bottom".... Appropriate for whom?? If you were a hedge fund with a significant short interest and had to cover... wouldn't it be totally sweet to cover around a 34% return??
At it's current valuation, the major risk associated with SPPI is not the product line, revenues, outlook... it's the *significant* manipulation and short interest that's controlling the shareprice. When you buy SPPI shares you need to know that the pps can be taken either way based on the whims of the institutional investors.. particularly the active ones...
So, on Monday,.. I won't be surprised if the stock trades significantly up or down,..
I'm all for great degree of formal SPPI governance..... this is a needed area of immediate focus! Are you listening Raj? At some point, someone like Blackrock, or another activist fund will press for the change... and it *will* happen then.....
So let's stick to the facts...... what we know is your view.... but what we don't know is a.) your position b.) your motivation.... for continually bashing SPPI. You've repeatedly claimed your background and position are well established... and yet I've personally read every post you made since your 'inception" at least on this alias...
I probably shouldn't be wasting my time even having this dialogue with you considering that you'd have to be a lunatic to be a long with your published sentiment,.. therefore I'd say it's about 95% or greater certainty that you're either a retail short,.. or paid 'media specialist' for a hedge fund... which is it?
Again, I'm expecting you to *totally* skirt this question... and try to say that I'm simply a 'paid pumper'... Do you want me to put a copy of number of shares up on
It should be very clear what my background is... read my posts and readers *will* find my background... regardless of whether they agree with it or not... I could put a copy of 1 of 4 of my accounts up on photobucket... publish the link,.. and you'd still probably come back to say that I doctored the image...
* a 34% haircut for an acceptable short term bottom.... so that you can cover on Monday because some ignorant retail sap drank your toxic Kool-aid? Considering the rise of the stock for the past 6 days... I'm expecting some shorts covered and may be primed to jump in on Monday... hoping to shear the "faithful" once again.... my shares won't be available.
* CE Melph has been 'muted' is an outright lie... I'm not even going to give you the benefit of the doubt that you're ignorant of the facts... a bald faced attempt to deceive
* You can accuse Raj of every unpardonable sin... and I'm not a Raj lover... fact is.... under his leadership SPPI has 5 approved drugs... soon to be 6.
* You have not "sorrow" for longs...
Your motives look pretty clear from here!
LOL! .... I'll buy more shares,... but definitely not on the order of 95k more shares... My target was 100k shares.... so should be on track to acquire the remaining shares in 2015.
So, reflective of the 2,684,705 shares that traded after hours.... SPPI reflected a market cap of roughly $350M.
Looking at the trading activity it was established and heavily influence by a stream of 100 share trades... It's interesting to note that the heavy 100 share stream of trades started immediately around 4:30 EST.. and dominated the trades... kind of like... "regardless of the buys... we're keeping this priced around $5"... towards the end of the session the price moved up to $5.40.
Without a doubt there was a lot of institutional dominated short selling enabled by high frequency / small lot trades... The reality was if you had purchased or sold stock after hours.. it would have traded around $5 - $5.40 /shr.
Given the outcome of the Nevada ruling,.. the uncertainty of the DC case(s),.. and Fusilev-related revenue stream... does SPPI priced at $5.40 represent a buying/selling opportunity? My investment analysis to buy SPPI originally factored in a negative ruling outcome, and helped explain why SPPI's then-valuation of $500M was low in comparison to many other biotechs... Even in the worst case, the reality is that the Fusilev revenue won't disappear overnight, and there may be a higher residual stream than shorts are hoping for.
Added to the above, SPPI already has a pipeline of 5 approved products, another coming onboard, and great ones in the pipeline... This my frustrate my fellow investor stocks.toshort, but on Monday if I'm looking at a $350M biotech with the above characteristics... I'll be a buyer... My March performance bonus is coming... and I'll be a buyer of SPPI.... Can any of the shorts provide more than a 1/2 unintelligible paragraph of epithets and slurs to actually put forth an alternative view.... ?? bio? heinman? iome?
sts, I actually own this many shares... and yes... I was disappointed at the ruling but considered it a possible outcome.... I slept just fine last night!