Maverick, SNO is their last chance to show me they know what the hell they are doing. I have been supportive, I have been patient. I have also seen results turned into TLD release within weeks of data lock. I have seen this with great big companies and relatively small companies. I have seen this with a product that was stopped early and quite complicated in both the data and the delivery. In fact, it will probably be the most difficult product ever delivered to market and it was a blockbuster. I had heavy hand in making that happen. That data was released immediately, presented quickly, approved in a flash, and published oh about a year and a half later. The drug I am currently launching just got published about 6 months after approval and more than a year after presentation because that is how it is done. If it is not broken, and this process is the opposite of broken, you don’t try to fix it.
If I am to believe that the SAP was shopped around and received positive feedback from all including the only regulator that really matters, then any discussion of data complications leading to delay after data lock is absolutely bogus! You can’t have it both ways, either there was buy-in and things were relatively straightforward or there was not and things are messy. If that is the case, it is material information and should be disclosed to investors in a timely manner. A year and a quarter is way past timely.
I understand that the company was cash and resource strapped. Besides the fact that LPs decisions regarding Cognate are a huge piece of that equation, we seem to be able to afford two uplisting consultants way ahead of actually being close to uplisting, but we can’t afford a good medical writer, a publication planner or regulatory consultants?
You know what, we have a sayin in industry… time is money. She is out of time and out of money. Submission deadlines for SNO were well within reason. What is not within reason is not presenting the data at SNO.
Present the damn data already. I am sick and tired of excuses, ill-informed explanations, and all that other Jazz. Show some competence and present the damn data at a major conference like SNO. You want to show that you have no idea what you are doing, then present at some other little conference after SNO but before ASCO. That will make everyone from Wall Street to Main Street, Mayo to MD Anderson and all other Oncology Meccas believe in your data…NOT. Your target audience is SNO first, ASCO second, and ESMO third. Target audience…if they don’t understand that concept, they are clueless amateurs. That is where Neurooncology goes to learn and pound chests, AND medicine is back to live conferences. I just came from one and it had solid attendance with virtual participation to boot.
That is kind of like publishing in JTM rather than NEJM or Neurooncology. The world took notice of that one, remember? What a rocket ship that publication produced. That countdown only took about two and a half years for a successful test launch. Now add another year and a quarter and people here are trying to temper expectations. Has anyone considered that LLs reputation will suffer a little bit and that faith in the data could suffer quite a lot if they miss this opportunity?
Drugs that get delays usually have expectations drastically reduced because the delay creates doubt and competitive opportunity. Anything after SNO will be hard to explain to the medical community and is a delay. Using Wall Street as an excuse will likely have the opposite of the intended affect with physicians, especially if this drug is priced anywhere near where it is worth.
If they are not presenting at SNO, they better have a damn good press release or we will have Big Trouble in Little China. I don’t know how much longer I can hold my allies together on this one. They will start to bail soon which is probably the intended consequence to deciding to skip SNO. No SNO and I am fully on board with the idea that the subsequent stock drop is engineered for insider friendlies to buy low when the next raise happens.
