The video is available to view on "top documentary films" web site. I only wish they were farther along in clinical trials. It's on my watch list of "safe" biotech investments.
MJ is for nausea in general .. not just for cancer. If you get a bad flu, try using an inhaler with some MJ and you'll be amazed how that nauseous feeling is immediately relieved.
That target was posted before the acquisition that brought in the melanoma treatment... so IMHO it's for AMR-001 only.
Already been done with contact lens.
Here goes for the fifth time since yesterday.. YAHOO keeps deleting my posts. Yes, I noticed I should have used resumed instead of restarted. The 90 day clock starts after the submission is accepted. FDA web sites states it normally takes 15 days for the initial review before the 90 day clock starts. I think the FDA overshot the 15 day review period... but we don't know because Venaxis never told us when the submission was accepted. Right now there's a lot of uncertainty here, that Venaxis needs to clarify if they want investors to return to the stock.
IMHO when the FDA accepted the original submission, they conceded the results were good enough for approval (I was wondering about the specificity). Perhaps Venaxis may need to provide some AI on the device (APPYReader), but given it's already approved in Europe (2013), that gives me hope the device requires no re-design. I can't see any reason to require another human trial unless APPYReader is deficient in some way.
MNKD totally messed up their second FDA submission due to the inhaler. The inhaler was designed to be cleaned and re-used indefinitely. However, the trials showed there were problems with that process, so MNKD tried to switch to their smaller, disposable inhaler in the middle of the trial. FDA issued a CRL for that ... and cost MNKD another $100M +.
DSCO resubmitted around five times due to drug manufacturing facilities... and they still had problems after that during the rollout.
Note the ball is mostly in APPY's court. They have 180 days to respond and if all is in order, the 90 day review clock restarts. Hopefully they will work with the FDA to get it right the first time around. There are consulting firms that specialize in managing the entire process. MNKD used one to help them through the process. I wonder if APPY did?
From the FDA web site:
A. Response to an AI Request
A response to an FDA AI request is the submission of additional information, addressing all of the deficiencies identified in that AI request, that allows FDA to continue or complete the substantive review and reach a decision on the 510(k) submission.
The submitter should provide a complete response to an AI request from FDA. The response should address all of the deficiencies identified by FDA in its AI request.
The submitter’s submission of a response to an AI request is an action that, upon receipt by FDA, resumes the FDA review clock, i.e., the 90-day review clock resumes upon receipt of the additional information.
Note: If FDA determines that the submitter has not addressed one or more of the deficiencies identified in the AI request, the review cycle will be terminated until FDA receives a response addressing the remaining deficiencies. In such a case, FDA intends to inform the submitter by telephone, fax, or e-mail that the response is incomplete and, therefore, the review clock has not resumed. In such a case, the 510(k) will be placed back on hold as of the date of the AI request, and the submitter will have 180 days from the date of the AI request in which to submit a complete response, or the 510(k) will be considered to be withdrawn.
If the submitter submits unsolicited additional information that constitutes a new indication for use or a new technology, because this information would essentially require FDA to restart the substantive review, the submitter will be required to submit a new 510(k) and the associated fee.
Thanks for the info. The first biotech that I was in that did a RS was CMSI. It is still around under a different name: BLFS. I sold C before they did their RS.
This sounds like ZLCS where mgmt had a RS ready if needed, but never did it. I wonder if DVAX mgmt wants to have rights to enact a RS if the price slips below $1?
I'm currently in MNKD, MACK, NBS, APPY (took a wild ride today). Have made a good $$$ in MNKD and MACK. NBS is a long shot and is only a phase II trial, but BAX has a similar phase III going in parallel and NBS is working with BAX on that trial.
APPY got its first set of questions back from the FDA on their submission and looks like shorts pounced on it thinking it was an outright rejection.
I'm also in LVL, DWX, SDIV, KBWD, CEFL, DVHL, LMLP and cash.
Most of the ones I've seen do a reverse were pretty much forced to in order to stay listed. A couple stated the reason was to exceed the magic $5 threshold to attract additional institutional investors. If timed with a positive catalyst an RS seems to have no detrimental price effect and could possibly attract some new investors.
I was in Citibank when they announced their RS, so I promptly sold it. Glad I did because the RS resulted in a pretty significant price drop
IMHO this is an expected part of the process after the initial 90 day review period. If this is a CRL and the company didn't report it as such in their press release, they just invited in the legal vultures to pick them clean
I have to fault the company for not providing more clarity... but this is the same mgmt. that put out a press release on the last offering that completely omitted the warrants (bringing down the offering from $2.40 to $2.14).
Thanks. I only buy individual stocks in the biotech sector. Small biotech stocks are easy to hedge around a single binary event. Also they have high IV so the calls are usually pricey. I just sold calls for $9K on MACK for a single month out (aug). That probably won't happen again next month, but you can generate some decent short-term income from high IV biotechs.
I'm targeting DVAX as my next biotech target to buy. I like to stake a position before the crowd assembles, usually 9 - 18 months out, then sell out-of-the money covered calls on my shares to make up for the extra time.
What concerns me is that the posts about a possible RS. Any opinions on whether this is just message board BS or is it a real possibility. It would seem to make no sense to me for DVAX to do a RS at this time. I've been in other biotech stocks where a RS was tried to attract institutional investors and it's always failed to do so.
We're not in a bubble overall. We're just about where we would have been if the 2008/2009 takedown had not occurred.
Yellen seemed to be trying to prevent another 1990's style tech bubble forming around some sectors of the stock market. I give her credit in attempting to learn from Greenspan's mistakes. IMHO though, her words will be forgotten in another six weeks, the biotech sector will regain its losses, and the traders will have profited nicely from the Yellen induced volatility.
Amgen made a buyout offer for HGSI around $33/share after Benlysta approva, but mgmt. was so overly optimistic they turned it down. GSK then bought them around 14.75/share after HGSI's price imploded to $7. GSK's CEO publicly boasted how they played HGSI to get it cheap. If MNKD's partner is to be GSK, who's to say they won't repeat the same s$$t they pulled with HGSI?
Maybe buy options instead? You can buy Jan 15 $5.50 strike for $4.70. That will allow you to profit on any partnership announced before Jan 15 by paying $4.70 instead of $10.00. Your cost basis would be 10.20 plus higher commissions.
There's a wall of call options due to expire the end of the week, so I would expect to see a price right below 10 by eod Friday.
phase 2, but researchers are interested not only in why something works, but also why it might not have worked... so IMHO you cannot make any assumptions regarding the outcome of the trial because NBS is presenting results at a conference.
Phase 2.... but it's important to note that Baxter is running a very similar phase 3 trial for a slightly different indication. You may want to follow Baxter as well as NBS even though you may only be investing in NBS.