RE:RE:RE:RE:The No News SurpriseYes, the science and the milestones are what will be defining moments for shareholders. I think what has stirred the pot is that, for better or for worse, being a public company requires a fair degree of communication with your owners. I don't think anyone here defines that as constant PR with silly, trivial announcements. Just the facts at important times.
A simple announcement, like below as many suggested prior to year end, would have filled the information vacuum and been seen as very professional investor relations, no meaningless IR. It would have been useful, credible, and built a bridge over to the first quarter. Just so easy that I'm a bit surprised they would not have thought of it themselves. Anyone with saavy around capital markets would agree I think.
This is purely hypothetical and made up by me.
"We are pleased to provide an update on our ongoing Phase 1a trial for TH1902. As we mentioned in our last quarterly update and in various investment meetings, all archived on our IR website, the trial is ongoing and there will not be a determination on MTD prior to calendar year end. It will likely be in the first quarter and is dependent on enrollment and how many successive dosage levels the trial accomplishes.
As noted in the past, full cycles and data collection per the FDA design have added a number of weeks between each patient dosing level. So far, we have enrolled a total of 12/?? patients, with a building wait list at 4 active recruiting sites. This has allowed us to fully test the 420mg/??level, which we previously reported was the dosage that led to one non-DLT neutropenia. Per protocol, we enrolled three at this level to determine if this dosage is safe with 2 or less DLTs in the expanded group level. This has been accomplished and we are gathering this data as we speak.
If there are no DLTs, we will continue with the dose escalation moving up to the 500 level with each patient, if not, we will move back down to the previous level which is 1.5x the normal dose of taxol and enroll a full complement of 6 patients at that level for the final safety test. Protocol stipulates if no DLTs at this level, we will define it as the RP2D level and move into the extension trial. Therefore, both the level the trial moves to and the patient enrollment and data collection time are the reasons for the trial moving in to the first quarter.
We will provide an update on the parameters of the extension trial upon finalizing discussions with the FDA. We look to move as quickly as possible into the second part of Phase 1. Additional study sites may be activated in order to get the full complement of 40 patients with sortilin overexpressing solid tumors in all 4 cancers we will be testing.
We look forward to updating the market again on the trial, the MTD and any data collected. At such time as we announce the results, we will organize the participation of our CMO, oncology KOLs and our new senior advisor Dr. Rothberg to discuss the trial findings in depth with our investors."
Now, was that so hard, misleading, or meaningless? I don't think so. It updated shareholders, employees, the press, the market, the analysts, etc... where the trial stands based on past facts released. If it had been done, there would be NO confusion as to where they stand, where expectations should be, and what the new timeline is. The presentataion could have easily been updated and not hidden.
On the other hand, maybe this is not what's happening at all. In which case, they need to clarify that too.
The frustration is that it's not asking for much at all, just don't be so silly as to contribute to the vacuum that already exists even more.
jfm1330 wrote: This board is crazy as it was during the long wait for Trogarzo's approval and we see now the same kind of complaints. Remember during the Trogazo's BLA review a delay was announced. It went crazy here with all kind of negative scenarios to explain it. In the end, everything was fine, the drug got approved, the SP rose above 14$ and almost nobody took advantage of it. 14$ was only the first step, it was supposed to go much higher. This board went from too negative, to unrealisticly positive. This missed opportunity to make a lot of money is the real reason for the general frustration here, not the last financing which was a necessry move.
This time the really important thing is the result of the phase Ia. We need a clear proof of concept, or at least a strong indication that the concept works. After that it will be phase Ib and that will be the new very important thing and the new waiting period. Imagine where the company would be if Tanguay did not give the green light to the acquisition of Katana. At the time it was seen as a minor gamble by almost everybody here. I saw it as a good unexpensive educated guess, a good strategic move. But, hey, Tanguay was seen by many as an incompetent fool. Now it's the turn of Levesque. Heroes have a short shelf life around here...
ANALIAS00 wrote: It is not the first time they are doing this (removing the presentation for a long period). So to me it is just a bad habit and they just believe this is not important to them. But to me it is an important detail among many others that can make a company to look attractive or not. Details are what makes a difference between being below average or above average. The presentation should have never been removed but simply replaced overnight with a clear notice on their website stating that a new version is now available. I also believe they should be updating their shareholders in a way or another on where they are at with their phase 1a. Not saying they should be providing prematured result but at least when they believe they could be providing us with some result. They could also inform us that results may or will take longer than expected as long as they keep us inform. This would be an improvment in transparency and also help building momentum and expectation (good or bad). I am also disapointed about PL intervention in the article. What is he trying to do ? Unfortunaly I am losing confidence. My confidence in him was very high. I now feel that he is just taking himself to seriously and giving the impression that he has a very high impression of himself. I dont like that. I now believe he can come to shareholders with no shame and annouce us that a not friendly dilutive financing is required and go on with it. He needs to rebuilt my confidence. Good result or not, he and TH must improve their communication to actual shareholders and to the potentials one.
SPCEO1 wrote: Once the corporate presentation came out with no significant new info, we already could be pretty confident these meetings will not yield anything too important. My best guess is either they were very lazy or very overworked and could not get the presentation replaced in a timely fashion or something TH was hoping would happen didn't actually happen.
realitycheck4u wrote: As there was no news release thus far, it is very possible that they are going to have discussions about nothing new. Wonder how that goes down.