MSBT: A comment regarding MedaSorb:
Hi Vinny,
Thanks for the follow-up on msbt, however i forgot to mention what is your opinion about the recent 10K and the enrollment that has somewhat picked up according to management, and moreover their ability to continue operations without any extra cash throughout Q3 2010.
thanks VFC's Take: According to the 10K, enrollment has picked up, although it is also stated in the document that the pace has still been slower than expected. The time frame given in the 10K is what I used as a reference when stating in my post on Wednesday regarding this company.
Since the company feels that there is enough cash on hand to fund operations through the third quarter, I think it is safe to assume that a cash-raising event is a possibility before then - part of the reason that I think we could see ten cents or below again.
With the acceleration of enrollment, there is a chance that the trial could be completed before the third quarter, but I'm more inclined to believe what I read in the 10K than assume that enrollment will pick up. I also believe that even if the trial does meet enrollment earlier than expected, the company will still have a need to raise cash to fund operations until the product moves through the regulatory process.
Another scenario would have MedaSorb bringing a partner on board that would supply an up-front payment in exchange for a cut of future CytoSorb revenues, but I get the impression that they want to go it alone, at least in Europe.
Regardless of any possible funding initiatives, with a market cap of roughly ten million right now, there will be a lot of room for MSBT to move to the upside as the CytoSorb story develops.
All just my own opinion, each investor should do his or her own DD and invest accordingly.
Disclosure: Long MSBT.
An email regarding Nephros and MedaSorb:
To: VFC,
Glad to have you back and i hope u enjoyed your holiday. As always, i find your "reasoning" and DD worth the time to read through and analyze. As such, i'd like to know of your opinion with regards to the following stocks:-
1) Nephros
- The recent deal with Bellco (Distribution) and Steris (Development) has much being said about it. A few scenarios have come about such as Steris's payment of 100k is to somehow "mark their territory" on Neph's patented technology. In addition, it could also mean that there is more likely of a future buyout of Neph as a whole or one of licensing.
- Neph's CEO resignation BUT still engage Elgin as a "consultant". What do you make of this? My take (again due to speculation) is that Steris could buyout Nephros and place someone from the company (Steris' B.o.D), but at the same time still need the services and technical expertise of Elgin for Nephros technology.
- FDA, we're close to a year if not already for the FDA to approve / disapprove its application ESRD. What gives...?
2) MedaSorb
- We're currently at 60 patients. What's your opinion on them completing the trials before / on the 3rd Qtr of this year? Looks to me there's evidence of accelleration of patient enrollment and it is still very subjective that patient enrollment could increase a lot or remain stagnant.
- If my DD is right, Europe CE Mark approval is quite efficient where it could probably take a few weeks at most for them to issue a YES / NO on whether a particular application is approved or dissapproved? (This is of course if the trials are a success and CE Mark is applied).
- Seeing that Dr. Chan has somewhat avoided dilution recently, and the company has till end of 3rd Qtr or 4th Qtr of this year before it runs out of cash. Do you think by than they would already have a few companies / individuals in line who would be more than happy to invest msbt?
I hope the following questions does not sound too amateurish / naive on my part. As i've mentioned, i'd like to hear yourside and yes, at the end of the day, nobody can convince me but myself. DD on my part is in no doubt, extremely important.
Looking forward to hear from you.
Thanks.
D.
VFC's Take: I'll discuss the MSBT suggestions first.
MSBT: Regarding patient enrollment, it is possible that the pace could increase and the trial could be completed earlier than the first quarter of 2011 as referenced in the 10K, but I'm inclined to expect that enrollment will remain the same and that the company will need to raise cash at some point before the fourth quarter of this year. I wouldn't mind being wrong on that one, but it's best to remain grounded and have the patience to wait it out rather than expect a best-case-scenario.
As for the European approval process, I agree in the sense that the European regulatory agencies can be more efficient that the US FDA at times - but that is also hit or miss. I don't believe, however, that a final decision will come within a few weeks, that's expecting a bit much. Especially if the trial is completed late this year and the filing comes around the holiday season. You'll be hard pressed to find an open government-agency office in Europe at any point during the last half of December through Three Kings Day, so CytoSorb may have to wait.
In response to your last comment about funding, I don't think that the company will have any problem raising the needed funds, barring any unforeseen setbacks in the trial.
NEPH.ob: The most pressing issue for Nephros right now, in my opinion, is the FDA decision. While the recent distribution and development deals are highly relevant to the future of the company, things have to be somewhat on hold until the company receives a response from the FDA.
The latest annual report mentions that the company has not received a reason from the FDA for the long delay, they've just received the "still under review" response. It's tough to speculate as to why the FDA is taking so long, but no news is better than bad news in this case.
It's also not too far fetched that one of the government workers at the agency either lost some vital paperwork, spilled coffee all over it or simply forgot about it - it is a government agency, after all. It's also possible that this one just got put on the back burner - who knows, we just have to wait and place our bets accordingly, based on our own speculation.
The development deal with STEROS could be something that has been in the works for a while, but the terms of the partnership or intended acquisition won't be finalized until the ongoing FDA saga is resolved.
The CEO resignation could be a part of the STEROS announcement, but we're not going to see the details until after an FDA decision, in my opinion.
I still like NEPH as a HOLD right now while we wait.
Disclosure: Long NEPH.Don't Forget, Mother's Day is Just
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