Biotech Values

[oc631]

Anyone with thoughts on Prolor Biotech (PBTH)?

What irks me about this company is they appear to have licensed a viable platform (CTP) yet they continue to advance their bio-better compound (hGH-CTP) in style reminiscent of so many other scam-bios.

Perhaps worse.



1- To date they have only run small (under-powered), open-label studies in Israel (Israeli company/ I know) and Eastern Europe.

So why are they doing this with such a promising drug/platform?

Bulls might say to save money and reduce their burn rate while advancing the lead compound quickly. The idea being they can license the late-stage compound or better yet sell the company outright prior to phase-3 testing. If this is their strategy (IMO) they are being penny-wise and dollar stupid. Lack of solid mid-stage data can only weaken the case for doing a deal with large pharma on favorable terms. This may be a bet by PBTH that large pharma will pony-up for a promising platform (with weak supporting data) out of desperation with the patent-cliff issues within their own [large pharmas] existing pipeline.

2- PBTH offers no events, recorded events, or presentations to investors through their website nor do they host quarterly C.C.'s. The company was even threatened with delisting by the SEC earlier this year causing them to refile their 10K with some data updating the status of their pipeline!


So what's next? It's rumored they will run a pivotal, late-stage study (randomized, placebo controlled) with approximately 150 patients. The endpoint is similar safety and efficacy of once weekly hGH-CTP dosing compared with daily BID dosing of hGH under existing SOC. It's unclear whether this study will be run in the U.S. or internationally. There has been no mention of the company requesting a late-stage SPA but then again it's PBTH's policy to never volunteer information.


Most companies inform investors when they are working with the FDA on a SPA. I suspect requesting a SPA is not considered a material event (under reg-FD) until granted yet I would like to hear thoughts on this. Are there any examples of companies releasing a late-stage design containing a SPA in which investors, prior to the fact, were unaware of?