~ hop step jump everywhere with my Fox =^.^=
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XXII $3.67... new 52wk high!
APRI ---> $2.71 pdufa on February 17
CHFS ~ nice dd, ash ...in at $3.55
XXII ~ going up with volume almost everyday ~ imo, institutions are buying
PSPW ~ thank you for the update UHD :)
~ thank you eicoman for the nice PT article!
based on the the tiny market cap and float with buyout possibility + other pipeline, APRI might pass that $5.00 PT easy on the FDA approval news.
all imo and good luck to us! :)
thank you.
i agree, ash.
a few ST posters were bashing so hard.
i agree, it should go up a lot higher, imo.
NURO should go $4-5
APRI should go up from here ~ pdufa is approaching fast (Feb. 18)..small cap and small float.
your NURO ~ wake up ash, please! :) up huge! congrats again and again!!!
interesting, ash...both down big, though.
accumulation day, i guess.
i try not to touch data play except eat and run ..EGR crashed on failed data this morning
TRPX ? .. bigcat, IZEA is not only for #blockchain staff... they have money making big business already.
yeehaaa!!!
very nice!!! ~ good morning ash and all ~ hope you all had a very nice weekend ~!!
pot stocks will bounce today - might too early to say but pot etf mjx is up nicely in early re-market.
exciting days ahead.
thank you everyone.
looks like many big event traders are getting in before the vote Wednesday ~ i won't be surprised to see the pps pass $2 mark within a few hours after open the market on Tuesday.
APRI ~ $2.73 pdufa 02/18/18 ~ excellent review post here
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=137660701
Since PH3 trials, even in the 2008 CRL, the FDA has not asked for any additional major clinical efficacy or safety trials for Vitaros. Just minor safety studies, updated statistical methods on efficacy(done) and CMC data. CMC issues have been addressed through the continued manufacturing for approved countries.
Here’s highlights of FDA communication from conf. calls since 8/16
Aug 4 , 2016 –
US Vitaros resubmission strategy. …. These activities include completing several new non-clinical studies, compiling a Phase 3 trial responders analysis.
We have conducted additional toxicology and pharmacology studies to best answer key questions. We have engaged several world-class subject matter experts to review our data and to help us to address these deficiencies, and we have established a productive dialogue with the FDA.
We believe that the majority of the CMC or manufacturing efficiencies have been previously addressed as part of the approvals in Europe.
Importantly, we will rely on the strength of the overall body of data and evidence that has been the basis for approval of Vitaros in 23 countries around the world. It should be noted that the current body of data include several new supportive studies as mentioned above, a new responders analysis from the original Phase 3 clinical studies and the extensive post marketing safety data from Europe, all of which were not previously available to the FDA for review.
Apricus Biosciences Provides Update on Vitaros NDA Following Receipt of FDA Feedback
Nov. 18, 2016 Specifically, the FDA provided clarity on the requirements needed to address the deficiencies in the 2008 Complete Response letter to include suggested additional analysis of existing clinical and non-clinical data. The FDA feedback did not indicate that new clinical studies would be required for re-submission.
. “Importantly, .... we can further strengthen our clinical benefit section in the planned re-submission, using a methodology provided to us by the FDA.
AUG 2, 2017
The NDA submission contains data that we believe addresses all of the issues raised by the FDA in the original Vitaros complete response letter. The results of our successful human factor studies, as well as a significant amount of supportive data from the Vitaros global safety database, which we believe enhances the Vitaros risk benefit profile.
we have continued to have a very healthy dialogue with the FDA along the way and with the division
Nov 2017
As expected, we are in dialogue with the FDA on an ongoing basis with respect to the submission.
. As expected, we - as I said, we have had a dialogue with the FDA. They have asked for qualification on certain issues, and we provided that.
Leading up to the decision date, we'll continue to have that sort of working relationship with the FDA. And so far, it's been very positive.
thank you eicoman and (also new and old-timers posters here) very much for your insights and very informative posts.
i'm still reading here and checking other places like yahoo finance to gather information since the pdufa is approaching fast.
APRI looks great, imo.
i might bet on this one ... 'bet' means i'm going to hold all my shares through pdufa- i rarely do that.
excellent review post, eicoman.
$WPCS ~ from PR on 12/18/17: A Special Meeting of WPCS stockholders to vote on the Merger is scheduled to be held on January 17, 2018 at 9:30a.m. ET at the offices of Morse, Zelnick, Rose & Lander, LLP, 825 Third Avenue, 16th Floor, New York, NY 10022 ---> https://wpcsir.com/2017/12/18/sec-declares-form-s-4-effective-proposed-merger-wpcs-dropcar-inc/ …
WPCS i won't be surprised to see the pps passing $2.00 mark before the vote on Wednesday - good morning ash :) do you know the time of the vote on Wednesday and when will we know the result? thank you as always!!!
~ very nice ash :)))
WPCS ---> $1.33 as i post
i kept small shares - not sure why the down trend.
APRI ~ yap! now $2.72 as i type!!!
APRI ~ i really like your view, BigCat and i agree.
$APRI $2.55 now ~ pdufa is set on February 17 ~ this is in my personal opinion only but after LPCN & ARDM i really think traders are coming here - and after $SGYP's pdufa on Jan 24, more people will come - here is good post ---> https://investorshub.advfn.com/boards/read_msg.aspx?message_id=137524856
i kept small shares
nothing big but could bounce from here, ash and if they send nice pr next week or so, the pps might skyrocket ... hahaha
very nice LN :) APHB $1.09.. i'm in at $1.04 for possible bounce play
APHB $1.09 crashed on financing ~ i'm in for a possible bounce at $1.04 ~ if there is no bounce next week, i will sell and move on.
vote probably will start at 4pm or so!
exactly ~ !