All very interesting speculation JD that gives shareholders much to contemplate.
An application for IND (investigative new drug status) would most certainly be well received and very proactive. Since safety/toxicity issues have been addressed it’s time to test Transcend’s therapeutic potential in humans. Also, I believe TTU (BTI?) can request an emergency IND from the FDA upon release of the latest study data. Thirdly, a Treatment IND can be submitted for serious conditions while final clinical work is conducted. The two categories are commercial or research. There is a 30 day wait before any trial commencement. See: http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm
I’m not sure if BTI can proceed on their own by way of physician request, but I believe they can….maybe via TTU?...but no doubt it would be easy for Roche to do….post deal with BTI. I suspect Shire could proceed very quickly now. I guess all ( Abbott, UCB, MedImmune) of them could because the safety factor with Transcend is there now…and all of the above pharma’s drugs have been proven in the market.
Your point that BT2111 is a threat for Roche is well taken JD. Thanks for that Forbes article. One thing that comes through loud and clear is the need for Roche to protect/renew the patent for Herceptin via a new drug entity, IE: BT2111. “The worry on Wall Street is whether Roche will be able to effectively protect Herceptin’s turf.” ...talk about motivation! The article points out that Roche may be able to expand breast cancer protection with a new therapeutic in New Vax , a cancer vaccine and they seem to think it could protect the patent….and that it has early positive trials. Seems to me BT2111 is the faster safer route at this time and that New Vax would only be additional support if successful .
Wall St. makes $ demands and time is of the essence…and, it’s ALWAYS about the money … as crass as it sounds. So, what will Roche do? It only makes sense that an IND application by BTI would demand attention, but then again, why waste the time? Time costs money. For any Pharma, erring through omission can be the biggest mistake of all.
As for all the others, the same applies…if they think Transcend is what it appears to be after 20 years of scientific research. That is what should scare them all and initiative may just win the day. Whether BTI has to ‘motivate’ them or not is a very good question.
I’m still a believer in RH and would love to know what is really going on as this is quite the Chess game now. He is in the driver’s seat and time is on his side. On the other hand, we all want to see the stock take off… as soon as possible.