ACELRX PHARMACEUTICALS Forum: Community User: Maroni

Da kommt die nächste Zeit einiges auf uns zu This upcoming year has many key milestones for AcelRx, including: Anticipated resubmission of NDA for DSUVIA in Q2 2018. Expected opinion on the Marketing Authorization Application (MAA) for DZUVEO from the Committee for Medicinal Products for Human Use (CHMP) in H1 2018. Expected FDA advisory committee meeting for DSUVIA in Q3 2018. Anticipated PDUFA date for DSUVIA in Q4 2018. Anticipated resubmission of NDA for Zalviso in H2 2018.

Mein einziges Problem sind die Finanzen. Viele Fehler dürfen die sich nicht mehr erlauben. Kann die nicht jemand übernehmen? ✌️

Doc, ich sehe es ähnlich wie du und hoffe, dass wir alle noch mit einem blauen Auge davon kommen.. Ich gehe morgen dennoch von einem Minus aus, sollte bekannt gegeben werden, dass die Zulassung für eine neue Einreichung bei der FDA kommt, dann sehen wir 40-50 Plus..

Nochmal zum Lesen für alle die Pressemitteilung

AcelRx Pharmaceuticals Reports Fourth Quarter 2017 Financial Results Mar. 8, 2018 4:06 PM - $60.5 million of cash and short-term investments at December 31, 2017 - Q4 2017 combined G&A and R&D expenses declined 27% from Q4 2016 and 9% from Q3 2017 PR Newswire REDWOOD CITY, Calif., March 8, 2018 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (ACRX), (AcelRx), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings today reported fourth quarter 2017 financial results. "As disclosed earlier today, we had a constructive meeting with the FDA regarding DSUVIA at the end of January 2018. In summary, based on the meeting outcome and official meeting minutes, we plan to resubmit our DSUVIA NDA in the second quarter of this year. The AcelRx team, including our consultants and our partners at the Department of Defense, did an exceptional job collaborating to reach consensus on a path forward to resubmission," said Vince Angotti, Chief Executive Officer of AcelRx. "We also continued to demonstrate financial discipline through control of our spending, and ended the year with over $60 million in cash and investments, which provides sufficient liquidity heading into an expected PDUFA date later in the year," continued Angotti. Recent Highlights The Type A FDA meeting on January 26, 2018 focused on addressing the two primary points in the October 2017 Complete Response Letter (CRL) regarding the DSUVIA New Drug Application (NDA). Official meeting minutes from FDA indicate proposals discussed in the Type A meeting were reasonable, which provides a path to resubmit the DSUVIA NDA in the second quarter of 2018. Completed preparation of Zalviso® NDA resubmission inclusive of positive IAP 312 study results on device functionality and tablet dispensing errors. However, AcelRx intends to hold resubmission until the second half of 2018 to focus on DSUVIA. Financial Information December 31, 2017 cash and short-term investment balance of $60.5 million. Revenues of $8.0 million for the full year 2017, consisting of $7.1 million from the Grunenthal collaboration agreement, and $0.9 million for work performed under the Department of Defense (DoD (DODSF)) contract for DSUVIA. In contrast, revenues from those two agreements for the full year 2016 were $6.4 million and $10.9 million, respectively. The year-over-year decrease in DoD contract revenue reflects our completion in 2016 of the Phase 3 clinical program for DSUVIA, which was reimbursed under the contract. R&D and G&A expenses for the year ended December 31, 2017 totaled $36.0 million, and excluding stock-based compensation was $32.0 million, compared to $37.0 million, and excluding stock-based compensation, $32.8 million, for the year ended December 31, 2016. This decrease is due to lower DSUVIA-related expenses resulting from the completion of the Phase 3 clinical program in 2016, offset by an increase in Zalviso-related expenses attributed to the Phase 3 clinical program completed in 2017, and a small increase in pre-commercialization expenses in anticipation of potential FDA approval of DSUVIA. For the quarter ended December 31, 2017, R&D and G&A expenses totaled $7.6 million, and excluding stock-based compensation was $6.6 million, declining $2.8 million compared to the fourth quarter of 2016. The decrease was mainly due to lower DSUVIA-related expenses, which included the filing fee for the DSUVIA NDA during the fourth quarter of 2016. See the "Reconciliation of Non-GAAP Financial Measures" table below for a reconciliation of the non-GAAP operating expenses described above to their related GAAP measures. For full year 2017, net loss was $51.5 million, or $1.10 basic and diluted net loss per share, compared to $43.2 million, or $0.95 basic and diluted net loss per share, for full year 2016. Net loss for the fourth quarter of 2017 was $9.9 million, or $0.20 basic and diluted net loss per share, compared to $9.7 million, or $0.21 basic and diluted net loss per share, for the fourth quarter of 2016. Net cash usage during the fourth quarter 2017 of $7.5 million included $4.0 million of debt service, inclusive of the payment of a $1.7 million deferred fee. 2018 Guidance and Expected Upcoming Milestones AcelRx expects quarterly net cash usage in 2018 to remain in the $10-11 million range before initiating pre-launch commercialization investments, which are planned to ramp after obtaining FDA approval of DSUVIA. This upcoming year has many key milestones for AcelRx, including: Anticipated resubmission of NDA for DSUVIA in Q2 2018. Expected opinion on the Marketing Authorization Application (MAA) for DZUVEO from the Committee for Medicinal Products for Human Use (CHMP) in H1 2018. Expected FDA advisory committee meeting for DSUVIA in Q3 2018. Anticipated PDUFA date for DSUVIA in Q4 2018. Anticipated resubmission of NDA for Zalviso in H2 2018. Conference Call and Webcast Information As previously announced, AcelRx will conduct an investment-community conference call today, March 8, 2018 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss these financial results and provide other corporate updates. Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers. Those interested in listening to a webcast of the conference call live via the Internet may do so by visiting the Investors page of the company's website at www.acelrx.com and clicking on the webcast link on the Investors home page. The webcast will be archived on the AcelRx website for 90 days following the call.

Dem ist nichts hinzuzufügen ... die Zulassung wird mit sehr hoher Wahrscheinlichkeit kommen und die Aktie in den nächsten Wochen sehr gefragt sein.. das bringt den Kurs noch vorne und einen ähnlichen Anstieg erhoffe ich mir wie vor dem ersten FDA Termin! Es hätte auch anders ausgehen können heute von daher lass uns einfach zufrieden sein! Top .. jetzt gibt's noch ein Gläschen Jameson 18 y. Und ab ins Bett. Euch noch einen schönen Abend ... ☘☘☘

Danke Olli77 ✌☘ ...

Zeitweilig nachbörslich 27% im Plus, nun noch knapp 17%.. Ohne die Zahlen heute wäre die Aktie bei 30% plus gelandet.. Für mich wieder Enttäuschend wie man das zeitlich organisiert hat. Ich hoffe das Management hat die nächste Zeit mehr Ahnung von der Materie als von Marketing.. Aber es gibt Hoffnung und das ist die Hauptsache..

Ich komm nicht rein

Aber es besteht berechtigte Hoffnung, dass die FDA einer erneuten Prüfung die Erlaubnis erteilt

Lies es

Fällt nachbörslich schon wieder.. aber insgesamt noch 20% Plus

Na ja??

Ist die Konferenz schon durch? Denke um 22.30 Uhr?

Die Zahlen sind na ja AcelRx Pharmaceuticals Reports Fourth Quarter 2017 Financial Results $ACRXhttp://www.seekingalpha.com/article/17097380

AcelRx announces receipt of Type A FDA meeting minutes and plans to resubmit the DSUVIA New Drug Application in Q2 2018 $ACRXhttp://www.seekingalpha.com/article/17097312