"does the FDA allow them to continue monitoring all patients "
The FDA has no say in GALE's decision to continue or otherwise.
"They can't be so desperate as to think the FDA would spend 30 sec "
Lying is not a desperation move for these guys, it's business as usual.
" No need for extra money"
You don't speak Greed?
If there's no secondary how are the scam guys going to fob off their free shares?
" they began procedures to see about STILL having it approved thru the FDA."
Won't happen. FDA will laugh. MM knows this and will probably discard the idea of submitting an application after he has wrung out all the profit from unwary investors that he can.
The delisting, if at all, won't happen for at least a year.
"If a company is in violation of the continued listing standards for a period of 30 consecutive days, the NASDAQ sends a "deficiency notice." The most common reasons for a deficiency notice are a share price that falls below $1.00 or a market cap that falls below the stated minimum (as low #$%$ million if other requirements are satisfied).
Once a deficiency notice has been sent, the company has 90 days to comply with the continued listing standards, or 180 days if the violation was for a sub-$1.00 share price. In order to be compliant, the company's share price or market cap must rise above the minimum for at least 10 consecutive days in the 90-day (or 180-day) period."
With an extension allowed
" Once the company receives the delisting letter, it has seven days to request a hearing with the NASDAQ listing qualification panel to present its case, which postpones the delisting process until the panel makes a decision."
"Remember -- 15% of shares are short"
And will stay that way through the bankruptcy.
The next dilutive wave will put the Share price well below a dollar with death spiral financing to follow.
", it may eventually make it to market." Never.
Look for insider shares to go on sale in any new secondary.
They may begin with dropping the exercise price of their options..
"I do believe everyone agreed that the expertise across the board is not there"
Their expertise has always been in parsing the best ways to fleece companies they are involved with and the shareholders thereof
" and the current situation is a result of it."
"1). Galena did not publish a press release stating instructing to the Idmc to discontinue the clinical trial.
2). Galena did publish a press release stating galena discontinues Nuevax P3 interm analysis."
Uh, interim analysis has already been done and reviewed, kinda hard to discontinue at this time. In fact GALE is planning on continuing an analysis of the analysis.
re 1)Galena Biopharma Discontinues NeuVax™ (nelipepimut-S) Phase 3,
re 2)PRESENT Interim Analysis based on Independent Data Monitoring Committee Recommendation
Schwartz-"...We expect to host a conference call next week to provide a preliminary review of the PRESENT trial and an update on ALL of our immunotherapy and hematology clinical development programs.”
IDMC letter-"On 24 June 2016, the assembled I ndependent Data Monitoring Committee met to rev i ew the EFFICACY and safety data available for the aforementioned protocol."
Schwartz (and others) "This planned safety and FUTILITY interim analysis was triggered after 70 qualifying disease free survival (DFS) events were reached, and a total of 71 events were reviewed by the IDMC."
If investigation by GALE of the data collected and presented to the IDMC by the CRO does result in a continuation of the trial I don't want to see anymore nonsense on this MB about a FUTILITY trial not being an assessment of EFFICACY.
" I just don't understand why the KL3 response was so poor."
Compared to subjective reported responses taken by poorly trained surveyors in a previous trial, you mean?
Ampion does not work, never has.
BK coming up.
Look for MM's next venture then short it.
From Jan PR-
"Did mgt commit in last CC that report/statement/PR would be prior to end of Q2 or by 6/30/16 ??"
From Jan PR
"Mark W. Schwartz, Ph.D., President and Chief Executive Officer, commented, “Galena’s strategy to advance our high value cancer immunotherapy clinical development pipeline has resulted in a progression to eight clinical trials ongoing or planned that are supportive of our core focus. Importantly, we expect to reach two key milestones in 2016 with the readout of our NeuVax™ (nelipepimut-S) Phase 3 PRESENT interim safety and futility analysis in the second quarter and the launch of a randomized, Phase 2b trial for GALE-301/302 in the second half of the year.”
From Q 4 CC; Schwartz
"Regardless to the exact timing around the 70th event, we still expect to announce results of the interim analysis at the end of the second quarter."
From Q 1 report
"“The first quarter of this year was significant for Galena as we achieved one of our key NeuVax milestones by reaching the 70th qualifying disease free survival event in our Phase 3 PRESENT clinical trial,” said Mark W. Schwartz, Ph.D., President and CEO. “Our clinical team is compiling the data for review by the Independent Data Safety Monitoring Committee (IDMC) and a recommendation of our interim safety and futility analysis is expected from the IDMC at the end of the second quarter."
"When do you expect to announce PH3 Interim results?"
"As soon as we have the recommendation from the IDMC we will make the
"the big 3 million plus share trade on the close was the Russell rebalancing."
How'd that affect the share price ?
"did not get all of what they were asking."
"The release set forth in Paragraph 13 on this point is
intended to be co-extensive with the requirements of the PSLRA. Specifically, if any claim for
attorney’s fees or defense costs incurred in defending this Action is asserted in the future against
Galena or any other Settling Defendant by any DreamTeam Defendant, that claim is barred if
and only if such a bar is required under the PSLRA, 15 U.S.C. §78-u(f)(7)(A)(i).
Further, the***Court expressly declines at this time to decide whether the PSLRA would or would not bar such
a claim, if one were to be asserted in the future."
No judgement on this issue.= partial
" I think the guy just wanted to know why the word partial below was used "
How hard would it have been to have had this queued up and ready to file?
Partial used as attorneys etc did not get all of what they were asking.
The settlement in full was submitted in March, iirc, any wanting specifics can find it via Google search of the case No. 3:14-cv-00382-.
"What's it say?"
In reply to Geoff Wolfe
Adam Feuerstein @adamfeuerstein 3h3 hours ago
. @geoffwolfe It should not take 12 weeks to perform an interim futility analysis. 12 weeks is long time for final analysis! $GALE
Adam Feuerstein @adamfeuerstein 3h3 hours ago
$GALE is taking a long time to complete what should be a simple futility analysis of the Neuvax phase 3 study.