Good luck to you, John. I hope they find a fixable problem for your sake since you probably invested tons more money in LPTN. I put back a little gambling money in this today after selling almost all a month ago to take tax losses. I just avoided the wash sale.
Pfizer was supposed to have done a thorough due diligence before they bought in. Pfizer was supposed to closely monitor the quality of Isonep and the trials, and audited the cGMP manufacturer. You can see that incompetence also pervades personnel who are supposed to have the highest qualifications. I've seen work conducted in major pharma/ biotech and I've seen why some of their facilities deserve to be shut down by the FDA and some drugs recalled. The FDA simply does not have enough personnel to examine submissions and audit manufacturers thoroughly. I'm sure FDA also has its share of incompetent people.
Then again, the mess might have been in the Phase 1 trials. There are so many investigators out there who do not do their jobs, fudge documents, and sponsors who do the same. Maybe that would explain why Scott always seemed really tentative when giving presentations. He may not want to lie, but he has to present lies.
I'm still really curious as to why Merck backed out from the "very promising" drug. Merck must have a very good reason to back out. For that reason, maybe I should plan not to add more gambling money. I've relearned a painful investing lesson with this stock. Or maybe not. I'm glad that my other stock gains more than made up for my losses here.
There are just too many reckless and untrustworthy people in the drug business. If not, we would be extremely rich investing in small biotechs with promising early stage data.
What I am thinking, as to why Isonep didn't do anything in NEXUS, is that QC was not properly done on the new manufactured batch. I don't know exactly how LPath does the quantification of antibody. Do they quantify based on binding to S1P as a ligand (activity assay)? What if the antibody was bound to S1P or perhaps other lipids/impurities (made by the production cells) in the final formulation and therefore are not free to bind anymore to S1P in the patients? Did they quantify the Mab based on concentration of Ab alone instead of S1P binding assays? Did they get low binding to S1P, but decided to push through with the trials anyway? Did they deviate from their original manufacturing SOP? Should they maybe hire an honest-to-goodness, self-critical, and very thorough scientist like myself to advise them on how to design their experiments to minimize their risks of failure?
Or perhaps Isonep just does not work for AMD and the ph1 results were simply screwed up or manipulated, like we longs were.
A major reason drug manufacturing becomes really expensive is that there are just too many incompetent personnel employed in the business, thus leading to high drug development failure rates.
They are non-responders to the last treatment, just like the non-responders to anti-VEGF in the Nexus trial. Catch my drift?
Been in and out. I feel like with the long wait to NDA and approvals, and with drugs similar to 1202 and 1101 that are already in the market, $17 is a little too high. 1101 will sell like a biosimilar. 1202 may be best in class. I'll be back when it goes back down to ~15. I'll take the risk of missing a buyout by Celgene or BMY.
Except that there are already 2 approved antibodies to CD20, in addition to rituximab, that MDs have been combining with Imbruvica for CLL. I'm not sure how much market share 1101 can get once approved. However, TGTX also has a differentiated PI3k inhibitor in 1202, in addition to the other newer drugs.
I am not sure whether this is a good buy at $17, or somewhat over priced given that approval for those 2 drugs may be 2 yrs away or more, and both have competitors in the same class of drugs..
I'm doing due diligence on AERI to decide on whether to ride this back to 35 or short it if pps goes up more, and saw a paper on the use of once a day travoprost and timolol. AERI ph3 just looked at superiority over timolol. What is your take on the travo/timolol use vs Rhopressa latanoprost? What is supposed to be the advertised advantage of Rhopressa over the travo/timolol combo?
Do you think deletion from Russell index contributed to the Grexit debacle? ARRY had a huge drop vs my other btechs.
I'm impressed! The future looks bright. Company seems to have brilliant scientists and mgmt seems to know what to do with the science. Profitability in 2018 and no need to sell new shares. Revenues will probably equal burn rate by early 2016. Clearly a buyout prospect.
The only question is at what pps should I go all in before more good news drives the pps up higher?
IMGN has ~270M by month's end which is enough to fund operation into 2017. Add partner payments to that. But I wouldn't mind if shares are offered if pps touches $17-18. In the meantime, the partnered ADCs will mature and bring in more milestone revenues, at the same time continue to validate the ADC technology.
853 result is from phase 1, but the patients are non-responsive to standard platinum/taxane treatment. Some partial responders may later convert to complete response. Since the patients are refractory to standard treatments, ph2 results may be enough for an NDA filing.
BT-062, which IMGN can opt in, gave good ph2 results. That would be the product that would be most advance, and for which IMGN will have a large share of revenue.
Very slow retreat, Goducks. You might not see $10 until 2 or 20 yrs from today. It maybe better for you to follow some other stock.
Screen for integration events in the HSCs before transplant will definitely reduce the risk. Is that part of the protocol? A single cell PCR perhaps, but it will be time consuming and labor intensive to grow separate transduced cells. The risks of microbial contamination also increases. It does not seem to be practical. Perhaps a PCR of the pooled transductants right before infusion, using primers specific for the lenti and known oncogenes will at least provide an answer. Even that may be tough to validate.
Anyway, today I decided to play it safe and buy AMGN instead. BLUE will have to wait.
Faosto, can you give me a good paper on these self-inactivating constructs? I read one paper on lentiglobin from the BB site, and it still talks about random integrations, although there was evidence on less preference for promoters/oncogenes.
At the end of the day, or FDA reckoning day, it will come down to risk/benefit. Maybe the risk will be considered by the FDA to be extremely low and the benefits to be huge. What will be considered tolerable risk? One good thing is that there are good drugs for liquid cancers now.
Yes, I wish I bought at $40, but my skeptic science stopped me. Without a definite FDA nod to the technology, as an investor, the price now presents too high a risk/reward ratio. Hope I'm mistaken.