All is possible.
1. Mfg issue resolved, check
2. Clarify efficacy results should stand without another trial, pending (June)
So #1 is already resolved.
If #2 can be resolved during the FDA meeting....
Where will the stock be?
Approval = $??
There's no way you'd see a real-time filing as insiders can wait 10-45 days before announcing anything so your words are bull shiitmuslim. Or the Roberts you are referring to is a small potato under 5 percent so s / he doesn't matter anyway.
"'Qualified Institutional Investor 13d-1(b) within 45 days of the end of the calendar year in which the beneficial owner acquired more than 5 percent and within 10 days of the end of the calendar month in which the beneficial owner acquired more than 10 percent
Passive Investor 13d-1(c) within 10 days of the acquisition of more than 5 percent but less than 20 percent
Exempt Investor 13d-1(d) within 45 days of the end of the calendar year in which the beneficial owner acquired more than 5 percent."
Shorts are totally desperate now if you ask me.
Search "Acceptance of Foreign Clinical Studies - Information Sheet" at the FDA website.
The Food and Drug Administration (FDA) MAY ACCEPT clinical studies conducted outside the United States in support of safety and efficacy claims for drugs, biological products and medical devices.
"Under 21 CFR 312.120(c)(1), FDA WILL ACCEPT a foreign clinical study involving a drug or biological product not conducted under an IND."
CHMA falls in the latter because Octreotide is already approved. The difference is the clinical trial based on the oral capsules.
When this is confirmed, expect a return to higher levels. Wait for the EU Phase III result which is in progress.
Dec. 31, 2015 = $148.8M
March 31, 2016 = $134M
Burn rate approximately $14M
Stock is trading 3 quarters into the future, today, so any positive announcement such as being able to use the European Phase III results which money is already allocated for, and the stop goes up huge.
I predict back to $12 within 60 days because at the FDA meeting the company will request if the 150 patients enrolled will be good-to-go.
Will go back up to $11 to $16 when FDA agrees to use EU Phase III data meaning cash reserves already allocated!! BOOOOOMMMM!
Say goodbye to your money shorts.
Fidelity, Vanguard, etc. etc. etc.
The wealthier they are, the stronger they become from good due diligence and research that they can afford.
Th poor, poor, shorts are going to continue being poor.
List of who's going to be banking millions.
Top Institutional Holders
Holder Shares % Out Value* Reported
Abingworth, LLP 2,080,595 8.57 40,717,244 Dec 31, 2015
MPM Asset Management, LLC 5,681,544 23.40 111,187,816 Dec 31, 2015
AllianceBernstein, L.P. 619,500 2.55 12,123,615 Dec 31, 2015
Franklin Resources, Inc 609,240 2.51 11,922,826 Dec 31, 2015
Rock Springs Capital Management, LP 487,500 2.01 9,540,375 Dec 31, 2015
FMR, LLC 3,126,325 12.88 61,182,180 Dec 31, 2015
BlackRock Fund Advisors 477,759 1.97 9,349,743 Dec 31, 2015
Millennium Management LLC 311,300 1.28 6,092,141 Dec 31, 2015
Pier Capital, LLC 281,017 1.16 5,499,502 Dec 31, 2015
Massachusetts Financial Services Co. 245,178 1.01 4,798,133 Dec 31, 2015
Top Mutual Fund Holders
Holder Shares % Out Value* Reported
Fidelity OTC Portfolio 349,820 1.44 3,603,146 Jan 31, 2016
Franklin Strategic Series-Franklin Small-Mid Cap Growth 311,700 1.28 6,099,969 Dec 31, 2015
Fidelity Blue Chip Growth Fund 298,351 1.23 3,073,015 Jan 31, 2016
iShares NASDAQ Biotechnology ETF 269,177 1.11 2,772,523 Jan 31, 2016
Alliance Bernstein Small Cap Growth Fund 230,453 0.95 5,240,501 Oct 31, 2015
Franklin Strategic Series-Small Cap Growth Fund 206,600 0.85 4,043,162 Dec 31, 2015
MFS New Discovery Fund 149,659 0.62 3,320,933 Nov 30, 2015
Fidelity Select Portfolios - Biotechnology 127,365 0.52 1,311,859 Jan 31, 2016
iShares Russell 2000 ETF 118,710 0.49 1,222,713 Jan 31, 2016
Vanguard Total Stock Market Index Fund 115,872 0.48 2,267,615 Dec 31, 2015
Gap Up coming...
Too bad for them.
They gambled on a drug about to get approved with just a few more inches from the finish line....will trade up closer to approval date. Near term will spike first higher than IPO and then the massive GAP UP, quickly after.
You actually think large funds who invested over $20 will lose on their investment. Shorts are naive!!!
FDA hiccup to all those waiting for the big pay day will bring the price to 1/3rd market potential. WATCH
It'll stay in the same range and the company will fix whatever needs to be fixed for a fast turn around. Shorts are wishing for profits they will never see so their desperate attempts to persuade you to sell cheap is their obvious goal. The drug is already approved so this is not a rejection. lol It's a change to the much needed oral version.
Last change to buy before TPE is proven (FDA approved) and bidders for the company start calling.
There it is. 1:24 in the trailer FITBIT SURGE watches
The journey begins for the stock price...