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AcelRx Pharmaceuticals'( ACRX) DSUVIA (sufentanil sublingual tablet) went beneath astute analysis by the FDA’s Anesthetic and Analgesic Biologic Articles Advising Board (adcom) on Friday. Afterwards a continued day of presentations and debate, the board gave a 10-3 vote for advising FDA approval. Trade was apoplectic throughout the day because of the adcom event, but was unhalted at 4:45 PM EST. Already trading resume, the allotment bulk rocketed to $5.00 and concluded the day at $4.92.

ACRX has had a airy anniversary with the appointment certificate debacle, recovery, and FDA advising board to accomplishment it off. Investors should apprehend this animation to abide in the accessible weeks as we access the estimated PDUFA date on November 3 rd. I aim to abridge the contempo events, accommodate some accomplishments on the events, and activity some abeyant strategies.

AcelRx Pharmaceuticals is biologic aggregation committed to developing and commercializing avant-garde medical therapies for astute pain. AcelRx’s activity (Figure 1) contains two late-stage artefact candidates, DSUVIA™ (DZUVEO in Europe) and ZALVISO®. Both accept been developed appliance the company’s non-invasive, sublingual conception technology to bear sufentanil, a constructed opioid pain-relieving drug.

Figure 1: ACRX Activity (Source ACRX)

AcelRx is currently aiming to get DSUVIA and ZALVISO FDA approval in the U.S., but they are already accustomed Europe. The European Commission accustomed both DZUVEO (DUSVIA) and ZALVISO) for the administering of astute moderate-to-severe post-operative affliction in developed patients in a hospital setting.

Source

DSUVIA (previously ARX-04) is a sufentanil sublingual book developed by AcelRx, for the administering of moderate-to-severe astute affliction astringent abundant to crave an opioid analgesic and for which accession treatments are inadequate, in developed patients in a medically supervised setting. The sufentanil is dispensed in a distinct dosage applicator (SDA) (Figure 2) which is a adverse to the archetypal methods of administering (IV, Articulate Pill).

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Figure 2: DSUVIA (Source ACRX)

Sufficient affliction administering afterward a anaplasty or activity is astute for healthcare providers. Addressing a patient’s affliction levels has become acclimation act for providers due to the opioid crisis in the United States. Opioids are frequently a accustomed affiliate for affliction administering in hospitals and healthcare establishments. However, there is an anytime growing corruption of opioids, and has become a focus of authoritative agencies. Although there is aggregation of accustomed analgesics on the market, DSUVIA aims to be the antecedent sublingual sufentanil artefact on the market.

DSUVIA is recommended to be administered by a healthcare provider on an as bare base with a minimum breach of one hour amid doses. The healthcare provider is to bear the book sublingual via the SDA (Figure 3).

Figure 3: DSUVIA Directions (Source FDA)

AcelRx sees DSUVIA to be the acknowledgment to an unmet charge in the astute affliction area. Figure 4 displays how DSUVIA would ample the charge for a fast acting, non-invasive affliction abatement for astute pain.

Figure 4: DSUVIA Addresses Unmet Needs (Source ACRX)

AcelRx advancing to get FDA approval for DUSVIA in 2017. The aggregation submitted a NDA for the DSUVUA aback in February 2017. The analytic studies showed that DSUVIA was able in abatement moderate-to-severe affliction in patients that suffered an abrasion or anaplasty that adapted an opioid for affliction management. Unfortunately, the FDA issued AcelRx a Complete Response Letter CRL on October 11, 2017, and adapted AcelRx to:

AcelRx accomplished the animal factors study, and resubmitted its NDA for DSUVIA. FDA accustomed the revised NDA on May 24 th, and set a PDUFA date for Nov. 3, 2018, to complete its analysis of the drug.

On Wednesday October 10 th, the FDA appear the advising board appointment docs for DSUVIA. The allotment bulk plummeted bottomward about 50% pre-market Wednesday attributable to the bazaar misinterpreting key credibility in the documents. I accept best of the activity was due to anniversary annual algorithms that begin abrogating key phrases in the documents. However, the abstracts were absolutely bullish. Afterwards a abrupt but astute selloff, investors were able to assay and absolutely assay the documents. Best of the abrogating diction was amid in the appendix, which absolute the addendum from aftermost year’s CRL. Panic affairs angry into FOMO buying, and the allotment bulk rocketed up aloof beneath $4.00.

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The advising board was tasked to advised on the accident vs. benefits, and whether DSUVIA should be approved. The focus of the affair was to appraise AcelRx’s resubmission to abode the apropos that produced a CRL aftermost October. This included the assurance of DSUVIA in patients astute the best dosing proposed for labeling (30 mcg). AcelRx bargain the best circadian dosage from 24 to 12 tablets per day. To abode the abhorrence of missing tablets, the AcelRx adapted the instructions for use and accomplished an added animal factors study.

While watching the AdCom, I accustomed aboriginal on the basic affair of the board was the anxiety of abeyant confused tablets. This is justified because the nation’s accustomed opioid crisis. A ample allocation of the affair complex appliance of risks of abuse, mismanagement, and careless contact. Board associates discussed DSUVIA’s baby tablets, and the achievability that tablets could be absent during administration. Although the board could not accommodate any added methods to abate this risk; they did accommodate anecdotal accounts of added accident catastrophes that activity in healthcare settings. The achievability of accident opioid drugs is a problem, but the board associates did alarm absorption to the actuality that about any us or accessory could go missing in a supervised setting, and this accident is not absolute to DSUVIA.

In addition, the board discussed the positives of DSUVIA. One of which was DSUVIA’s adeptness to abode the abridgement of alternatives to IV or ingestible pills for affliction management. Not every accommodating or bearings will acquiesce the use of the acceptable IVs or pills. The fast acting sublingual book could be a aloft adjustment of administering in accurate affairs breadth IVs and pills are not appropriate.

Overall, it appeared the majority of the board agreed the allowances of DSUVIA in affiliation with the REMS appropriate by FDA abound over the risks. However, it was aboveboard that some associates didn’t see DSUVIA as a aloft artefact to the accustomed standards of care. The board is not answerable with accouterment their angle about the abeyant bazaar of a drug, but a few associates appeared to attempt with the abeyant appeal for DSUVIA.

Investors should booty agenda that the FDA advising committees are to activity absolute recommendations to the FDA on accurate and procedural affairs associated with abeyant articles adapted by the FDA. The FDA is not adapted to chase the administering of an advising board vote or recommendations aback finalizing decisions on applications.

PDUFA Outlook

Based on appointment docs and the advising committee’s recommendation, I accept the likelihood DSUVIA gets accustomed is strong. Added generally than not, the FDA’s approval judgement equals the advising board recommendation. Nevertheless, the FDA doesn’t accept to stick to the advising committee’s advocacy for approval. The FDA will accomplish its own approval decision, and it appears it is not an accessible one.

DSUVIA does accept affected the actuality it is a constructed opioid in this approval decision. Opioids are arguable accountable because of the accustomed cardinal of opioid overdoses in the United States, and DSUVIA has to prove it won’t accord to the crisis. Aftermost year’s CRL was based on assurance apropos of the best dosage labeling and abeyant of absent tablets. Both of those apropos angle out to me as opioid crisis generated fears at the time of the approval decision. The opioid crisis is still ongoing, and the FDA ability acquisition accession acumen to accord a thumbs bottomward to an opioid.

Conversely, DSUVIA should be able to acceleration aloft the stigma of opioids due to the actuality it advised for astute affliction in a healthcare setting. DSUVIA is administered by a healthcare professional, and is not assigned for at home use. The assurance abstraction accustomed that there is little affair of adulterated administering of the tablets, which could advance to confused tablets. Because these points, I see DSUVIA actuality aloft to articulate opioids (pills) that are generally self-administered in a us cup.

Moreover, DSUVIA is already accustomed in Europe (DZUVEO). Agnate to the advising committee, the FDA does not accept to chase the judgements of added authoritative agencies. Still, accepting accession aboveboard authoritative agency’s approval should be apparent as reassuring.

Finally, the actuality the DSUVIA was advanced CRL’d can absolutely be apparent as positive. Aftermost year’s CRL was aching draft to ACRX investors, but the aggregation addressed the apropos and was accustomed during the advising board meeting. The FDA would accept to ascertain a atypical affair to adios again.

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The aggregation and investors assume to be assured in approval, and if DSUVIA receives accession CRL, I apprehend a harsher allotment bulk acknowledgment to aftermost year’s CRL. I would brainstorm that some longtime ACRX investors would lose acceptance that DSUVIA and ZALVISO would get approval in the United States.

If DSUVIA is accustomed FDA approval, AcelRx is tasked with converting to a bartering date biologic company. Commercializing Dsuvia will crave a sales force. AcelRx anticipates to accept 10-15 hospital anniversary managers to bazaar DSUVIA for barrage Q1 2019. The aggregation anticipates to abound that force to about 60 by Q2 2020.

Assuming Dsuvia wins FDA approval, AcelRx should see some analyst upgrades and some accessible initiations. Investors should attending for a aggregation appointment alarm breadth the administering aggregation ability accommodate description of DVSUVIA barrage and affairs for ZALVISO.

Most of the accustomed absorption is on DSUVIA, but the aggregation does accept a agnate artefact ZALVISO; accession sufentanil/device aggregate product. ZALVISO is advised to bear 15 mcg sublingual sufentanil tablets by agency of a hand-held, patient-controlled arrangement (Figure 5).

Figure 5: ZALVISO Accessory (Source ACRX)

ZALVISO is agnate to DSUVIA attributable to the aforementioned drug, and indication. However, ZALVISO utilizes a altered device, dosage, and is accommodating administered. I can brainstorm the aloft annual of ZALVISO over IV PCA is the affluence of mobility. A accommodating with an IV of morphine will be tethered to the IV pole unit, admitting ZALVISO is not absorbed to the patient.

AcelRx submitted a NDA in November 2013 utilizing the absolute after-effects of ZALVISO’s appearance 3 studies, but accustomed a CRL on July 25 th, 2014. The FDA requested added advice on:

As a aftereffect of the CRL, AcelRx accustomed a acceding for accession Appearance 3 abstraction that was advised to appraise the all-embracing achievement of the ZALVISO device. However, the aggregation affairs to resubmit the NDA for Zalviso in the fourth division of 2018. This would be a blazon II resubmission and could abandoned crave a 6 ages review.

ZALVISO was accustomed in Europe in September 2015, and was launched by Grunenthal Group, AcelRx’s licensee in Europe, in the aboriginal bisected of 2016.

I see AcelRx as a buy aloof because the bazaar cap is about $250 actor and the estimated DSUVIA’s European aiguille anniversary sales is about $800 million. ZALVISO has displayed accretion sales in Europe through 2018 (Figure. If DSUVIA gets U.S. approval, the aggregation has projected aiguille anniversary sales for the biologic of $1.1 billion. This would best acceptable accession allotment bulk aing to $20.00 a share.

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Figure 6: ZALVISO Achievement in Europe (Source ACRX)

Recent analyst appraisement activity from Michael Higgins of Ladenburg Thalmann common a Buy, and aloft its bulk ambition from $7 to $10 afterwards the absolution of the appointment docs. Clearly he anticipates a FDA approval for DSUVIA, and a able artefact barrage in the advancing year.

My aftermost acumen for the buy advocacy is that DSUVIA is adjourned partially by the Analytic and Rehabilitative Medicine Research Program (CRMRP) of the U.S. Army Medical Research and Materiel Command (USAMRMC). I was acquainted of this acceding but it was during the advising board affair that I accomplished the potential. Combat breadth altitude ability not acquiesce or be acceptable for acceptable IV morphine alertness and administration. DSUVIA could be a safe and able advantage for these conditions. Not abandoned is the Department of Defense acrimonious up some of the bill, but additionally could be accommodate a ample government contract.

As declared above, if FDA decides to abjure DSUVIA afresh I would apprehend a able broker fallout. Not abandoned would this be crippling to DSUVIA, but I would apprehend a agnate aftereffect for ZALVISO’s resubmission. The FDA to appeal added trials comparing DSUVIA and ZALVISO to added opioid medications or analgesics.

Another accountable of affair is DSUVIA barrage and bazaar reception. Although I see the advantageous appliance of DSUVIA, the sales force needs to argue hospital staffs to accommodate DSUVIA into their astute affliction protocols. Perhaps with the accustomed opioid ambiance hospitals will be accommodating to add an accession like DSUVIA to the squad. It is accessible that DSUVIA is not accustomed by the market.

Another abeyant botheration is AcelRx’s accustomed activity of “Going It Alone” for bartering barrage DSUVIA in the U.S. does accommodate some obstacles. Investors should be acquainted that amid 2007-2016, the boilerplate 12-month sales for biopharma companies that go it abandoned was beneath than $25 million, admitting the boilerplate 12-month sales for companies that absitively to accomplice was about $44 million. With projected aiguille sales to about $1 billion, the bar is set actual aerial for DSUVIA. Investors charge accept that will booty abundant bulk of time to accomplish that akin of sales. Unfortunately, it does accessible the aperture for abrogating affect in the aboriginal abode of appear sales.

AcelRx does accept a advantageous banknote position in affiliation to their banknote burn. As of Q2 balance report, the aggregation has$50.1 actor in cash. In addition, a July disinterestedness alms provided $20 actor to the coffer account. Currently, the aggregation is experiencing a $10-11 actor annual banknote burn. Net accident for the aboriginal bisected of 2018 was $22.1 million, compared to $28.6 million, for the aforementioned time aeon in 2017.

However, it is accessible for the banknote bake bulk to access with the bulk of DSUVIA U.S. launch. It appears the accident of active out of banknote in the a appellation is minimal. Then again, is it abundant banknote to accumulate the doors accessible till DSUVIA revenues appear in? If DSUVIA sales beneath accomplish investors should apprehend a basic accession from an alms or loan. Because the access in absorption ante on loans, I would apprehend a accessory alms to be the choice.

Last but not least, is the blackmail of the opioid crisis in the United States. If affairs abide to deteriorate, I apprehend assembly and authoritative agencies to able bottomward alike harder on opioid pharmaceuticals. AcelRx’s articles could be a victim to a ample spectrum federal cardinal or regulation.

With the AdCom affair finished, I advanced the allotment bulk to be airy in the accessible anniversary due to the resumption of trading occurring in afterwards hours on Friday. Animation should abide aerial arch up into the PDUFA date. In my experience, I apprehend the banal to accept a countdown followed by some accumulation demography and accident abridgement as we get afterpiece to November 3 rd.

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Looking at ACRX’s blueprint (Figure 7) we can see the allotment bulk accomplished a countdown above-mentioned into aftermost year’s PDUFA…and agitated sell-off aloft CRL.

Figure 7: ACRX Circadian Blueprint (Source Trendspider)

I accept the $5.75 band generated from aftermost year’s countdown above-mentioned to CRL will be able resistance. Notice the trend band generated from the $2.00 abutment and the $4.21 aerial generated by European approval in June. I see that trend band to be the accustomed trajectory, and I will use it to actuate if the accustomed advancement trend charcoal if DSUVIA is approved.

Investors attractive to authorize a position above-mentioned to PDUFA date should use some array of abstruse indicator or bulk activity to actuate an access point. I would acclaim the $4.20 breadth to be a notable S/R band to advice actuate entry.

If you are attractive for access afterwards abeyant approval, I would advance cat-and-mouse for analyst updates and/or stabilization in allotment price. Biotech stocks are belled for “sell the news” and I doubtable a appropriate bulk of abbreviate appellation traders to advertise already their ambition bulk is hit.

Personally, I planned to sit on the sidelines through PDUFA date. Alike with the added studies, I was still afraid due to aftermost year’s CRL and the opioid environment. However, the appointment docs and adcom advocacy has provided me with some confidence, and I will seek an access point afore the PDUFA if the bulk is right. If approved, I will add to or admit a position already the allotment bulk stabilizes. I will add to the position if I see able sales in consecutive balance reports.

If AcelRx receives a CRL I will advertise and never attending back. The aggregation would crave added funds and I would apprehend ZALVISO to accept the aforementioned accommodation as DSUVIA.

ACRX is activity to be in comedy for abbreviate and continued appellation investors over the aing weeks and months. I apprehend day and beat traders to accomplish up a appropriate allotment of the trading aggregate up through the PDUFA. As for the continued appellation investor, I would assort this as a scrutinized advance that requires gestation. I don’t advance a beat drawer access of buy and analysis aback already a quarter. AcelRx is activity to charge time to get DSUVIA to abounding maturity, but will additionally crave the broker to accomplish surveillance on aggregation balance reports, and authoritative updates on opioids. If affairs about-face for the worst, investors charge to be able to avenue position with haste.

While Friday’s AdCom vote provided AcelRx investors with confidence, the success of the aggregation in 2018 rests on the FDA approval slated in November. If approved, DSUVIA will the aboriginal FDA accustomed artefact for the company, and will activity able tailwinds for ZALVISO’s abeyant approval. Nonetheless, if the aggregation receives a CRL, the aggregation would be attractive at a continued and boxy alley ahead. ACRX is not for the accident afraid investor, but i n animosity of that, I accept the contempo absolute contest and abeyant accessible catalysts accomplish this an appropriate investment.

Accurately admiration the banal bulk in the a appellation is perplexing. Because this, I would like to accent that AcelRx is an actual abstract stock. There is the abeyant that investors could lose all or a ample bulk their investment. Although the upside of AcelRx is substantial, it is a continued way from actuality a certain investment.

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Disclosure: I/we accept no positions in any stocks mentioned, but may admit a continued position in ACRX over the aing 72 hours.

I wrote this commodity myself, and it expresses my own opinions. I am not accepting advantage for it (other than from Seeking Alpha). I accept no business accord with any aggregation whose banal is mentioned in this article.

Editor’s Note: This commodity covers one or added stocks trading at beneath than $1 per allotment and/or with beneath than a $100 actor bazaar cap. Please be acquainted of the risks associated with these stocks.

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