SEC rules prohibit insiders from transacting in shares of they possess material non-public info.
Not sure if my interpretation is correct, that is why I brought it up; I wanted others to review the pieces of the puzzle to see if you all put them together the same way I did.
What other reason could there be for the company to pull/hide the listing off AVARX? They oviously had success with their listing of MM-398 on the site. It also seems curious that the last update was two weeks after Q2 call. This Q3 call they dial back the talk, is it because of confidentiality/non-disclosure clauses in pending deal?
Bob did say they were in late stage discussions on the Aug 10 Q2 call! Two weeks later, no more insider buys and maybe the MM-121 listing is updated to be hidden pending a deal closure 90 days out?
Date of last update for MM-121 listing on AVARX was Aug 24, which could have been when they hid the listing. Monday would be the 90th day from Aug 24th, could we get news Mon or Tues?
I can't imagine that they would pull the listing if they were still actively seeking offers from prospective partners. As recent as Nov 18 in London they said they were still in active conversations. Only reason to hide listing is because they are close!
Google Merrimack Pharmaceuticals and AVARX. You will find items where MACK listed MM-398 and MM-121 on AVARX site looking for development partners. AVARX is premier site where biotech firms post opportunities for business development. You will note that MM-398 shows as sold. If you then go to AVARX site and look at available opportunities you will see that the MM-121 listing which was most recently updated on August 24th does not show up under any search.
Also note that a PI trial combining MM-121 & MM-151 was filed and appeared on clinical trials site on August 31st, however no announcement of the trial or the dosing of first patient has been made by the company.
Has the posting for MM-121 been hidden on AVARX site because there is spending deal not yet closed at which point it too would show as SOLD? Has the announcement of combo trial been withheld because dosing of first patient under a deal triggers a milestone payment?
Company has been clear that development of MM-121 beyond PII NSCLC trial is dependent on a partner as well as development of MM-151. In both recent presentations at Credit Suisse and Jeffries, MM-151 PII trial in mCRC has been referenced as being a fast path registrational trial to be initiated in early 2016. Can it be that pending deal for both MM-121 & MM-151 is soon to be announced and that is why we have seen no insider transactions since the Q3 release?
Onivyde is currently being reimbursed under Medicare Part B, check ACCC website. I believe there is a window after approval by FDA which allows reimbursement at company price until CMS review and reimbursement limit established for part D.
From initial readout to final readout. Initial readout of NAPOLI was released after a fixed number of events (patient deaths), the final readout comes after all participants either died or were no longer on trial. The increase in neutropenia most likely came as results of increased incidence of neutropenia in the trial participants who were remaining after the initial readout data you are quoting than the patients the initial data represented.
I never said the plan was to wait until PII NSCLC trial to read out, I merely was saying that by illustrating that they have more than enough cash to get through the read out they can negotiate tough to get shareholders the best deal: just like they did with Onivyde/Baxalta.
I am very comfortable with the expected 121 NSCLC trial data. Docetaxel and Pemetrexed will both be enhanced by 121 better than erlotinib was in the previous lung trial; Heregulin is valid bio marker and trial was a formality to get breakthrough therapy from FDA IMMHO.
Based upon current cash, Q4 milestones, conservative 2016 net milestones, Onivyde sales and available LOC get them through 2016 and allows them to name their price and terms for 121 knowing they can raise the price even higher once they get data from lung trial which confirms the data from all previous PII trials.
I don't anticipate another secondary for this very reason: they have cash/potential through 2016 with multiple catalysts between now and then as well as in 2017, if a secondary were to happen it would only be after 121 readout IMHO, if at all.
Basically same info that was presented at Credit Suisse, but we did get more clarity as to timing of a few events. Onivyde PIII Gastric trial to be initiated early 2016, MM-151 PII mCRC trial to be initiated early 2016 and EMA decision on Onivyde in post Gem PC expected early 2016.
I believe the net milestone of $46.5 million is based upon the expected Onivyde PIII Gastric trial being initiated early 2016. I am not sure if management is counting any EMA approval milestone from Onivyde post Gem PC decision expected early 2016.
Now enrolling at 8 sites (6 in CA, 1 FL, 1IL) and 5 sites not yet enrolling (1 AZ, 2 NY, 1TN, 1 WA) as of 11/16.
FDA would not approve that as a trial design in this patient setting. How many oncologists are using FOLFIRI as therapy in post Gem PC? Answer: None, at best, very few! Your understanding of trial design fails to grasp that Oncologist's treatment history and willingness to place patients into trial based on study's treatment options. 5FU/LV not FOLFIRI or FOLFIRINOX is most accepted and used therapy in post Gem PC! Your assertion is flawed and indicates your lack of knowledge!
if patient gets at least two doses, this is illustrated in per protocol data: Onivyde + 5FU/LV OS 8.9 months; 5FU/LV OS 5.1 months. This is why when entering frontline patient population for PC Onivyde looks to be able to extend % of patients living past 1 year!
FOLFIRINOX showed 45% Neutropenia and 9% Neuropathy. Gem-Abraxane showed 38% Neutropenia and 17% Neuropathy. Ideally, modified FOLFIRINOX using Onivyde will show a better toxicity profile than both standard FOLFIRINOX & Gem-Abraxane while matching or beating efficacy.
MACK wholey owns both the industry's first antibody guided drug (302) and the first 100% EGFR signal inhibitor (151). 302 is in a registrational path PII trial which will read out in 2017 and 151 will soon also be in a registrational path PII trial. 302 design will enable it to offer a treatment option to Her2 intermediate positive patients who up until now have not been helped by current Her2 targeted therapies. Onivyde is on target to bring a modified FOLFIRINOX to the entire frontline PC patient population by significantly reducing toxicity without sacrificing efficacy. 141 is seeking to establish a way to enhance current SOC Gem-Abraxane. 121 will be first to readout on an ErbB3 targeted Heregulin positive NSCLC trial and will soon be partnered then becoming first to establish ErbB3 pivotal PIII trial in Her2 negative and triple negative BC.