Thanks falcon...I agree with everything you said. At this point arx04 and eu may get approved before zalviso. Interesting on your research that fda can back off...it was asked in the call if they had counsel advice to protest the fda commentary...he said too early to answer that until they meet with fda...while i agree, I don't have much confidence in their communication with fda. Per king on the call, their only "FORMAL" meeting with fda was that in September albeit a video conference. Rest of communication been back and forth communications for the protocols I presume via email. Leadership is certainly lacking and one person questioned if the leadership turnover may have prompted this fda decision....it's very telling that the terminated ceo is still put in front of the firing squad...this thing is salvageable but going to need some execution
At the end of September we held a teleconference with the FDA to review our proposed response to the Zalviso CRL. Prior to the meeting we have provided a briefing document outlining plans for our response to the aforementioned mentioned issues in the CRL.
During the teleconference with the FDA, we confirmed that bench testing could be an acceptable approach to evaluate the reduction in optical system errors, subject to Agency agreement with the test protocol and the target optical system error rate. We plan to submit the bench test protocol to the Agency for review and comment shortly. The protocol will clearly delineate all plan changes to reduce the optical system error rate, including addressing specific questions raised by the Agency in its written response to the company’s proposal.
To address the risk of inadvertent misplacement of tablets, we propose mitigations through the Zalviso systems and IFU, and to test these mitigations by way of a human factor study. The protocol for the human factor study is in the final stages of completion and will shortly be submitted to the FDA for review and comment.
In the CRL, the FDA specified that the appreciate test mechanism to evaluate mitigations for the inadvertent dispensing of tables is via a human factor study. We believe that the protocol we are preparing for review by the agency to evaluate the mitigations that we propose for this issue, should meet the requirements specified by the agency.
At the same time as we submit the human factors protocol and at the request of the agency, we will also provide a rational for why clinical evaluation of these mitigations is inappropriate and unnecessary. We hope to receive feedback on both of the items in the response from the FDA. The agency of course always preserves the right to decide on the adequacy of the design of a study to address any given question, as well as the right to determine if the date in that study satisfactorily addresses the questions being asked.
Yes, actually I do recall that...I remember the FDA did request from ACELRX for why further clinical trials would not be needed in lieu of Human Factor Studies. So we know that the FDA prompted them to prove their case. I guess what is confusing is the communication at the 2-24 conference, prefaced with an 8k filing, is that the FDA implied no clinical trials were necessary. So, either the FDA did a 180, the company was not forthcoming, or we the wording of the 2-24 presentation (now missing from website) has loose language
I have to go back and listen again, although I dont think i can put myself through that AGAIn. But someone did ask if they would seek legal action and the answer was the typical too early to consider until they talk to FDA. Now I am wondering if they have been forthcoming about clinical trials all along? That being said, their tone on the call was utter shock and unprepared to be honest. So perhaps it was thrown on them without knowing.
I will hold on to what I have...but I have to say I don't have much confidence or faith right now, perhaps I am too fresh off that terrible call. What really stings is that I was "this close" to selling Friday and getting out of here and trade it back. What a train wreck...
25 minutes reading risk statement...you can tell everyone's morale is shot...And a lot of "umm ummm uhh ummm" ridiculous...where the heck is the Adrian Adams
"an additional clinical study is needed to assess the risk of inadvertent dispensing and overall risk of dispensing failures." so what does this entail? are we talking about a clinical test on the device only WITHOUT the drug and testing and reporting of those p values or whole new ph 3 trial?
take that FWIW...of course if we are looking a complete new trial who knows...the disclosure said "new study" so we will see what that means after they meet FDA...until that time trade...
I think the market value has to stay at 250 mill at least....the only thing now keeping it here is the prospect of ARX04 and EU...that is worth 250 mill...but im not looking at this through rose colored glasses...not a happy camper and I agree with your post.
I agree - with a new clinical trial and money to do it means a lot of uncertainty and time. Time is a big expense too with less foothold of market share. I thnk the only thing holding this up now is ARX04 and the possible financial milestones they can get out of that. Additionally, I suppose a 250 million marketcap right now is the true valuation? While ACRX has its issues, 250 mill lot smaller than many other vapor biotechs.
thanks for clarifying and great point. I never thought about that angle of reducing RIGs to raise the price of oil...I have bought a few positions purely on an insider buy strategy but looking to establish more long term positions....I think this one has a log room to grow and can capitalize on the market share and weakness...thanks again
Why would a decreasing rig count benefit longs and sand? im new to doing DD on this one thx
yeah it will be a seesaw battle into the winter...especially after the 6 month wait after NDA filing there will be lots of volatility and fun fur trading outside the core