I was baffled by all the support PN was getting back in December, but I'm more baffled that those who thought he deserved to stay and didn't at least request that his compensation be changed to a merit-based compensation, where he only gets paid for accomplishing certain goals during the year. Instead, he is awarding himself and his incompetent staff with more money for doing nothing but missing deadlines and dragging this out as long as it possibly can.

I've heard rumors that PN reads this board, but I can't believe it at all. There is no way that an intelligent person could see all of their failures constantly complained about on this board, and still think he deserves bonuses and raises. The man is in over his head. He may have helped in many ways to get the company to where it is, but it has outgrown his capabilities, and I am certain he cannot drive the company forward. All he will do is ride the slow moving ship and tell us how great he is.

If we keep him, all we will see is the natural flow of the company when people are just doing a mediocre job. That means phase II will be submitted to the FDA at the very end of Q2 or they will miss the deadline all together and submit during Q3, and the phase II testing will take a couple of years. A true leader who is capable of running a phase II company would get us a product to market by the first half of next year. He would have had everything ready to submit to the FDA for completion of phase I and start of phase II within a couple weeks of completing the last patients in phase I. He isn't a leader, he is a follower who is just letting others dictate the movement of the company.

I did a little more research

The Bio-Path website says "Bio-Path holds a strong intellectual property position, including composition of matter patents for neutral lipid p-ethoxy antisense." I searched on Google Patents for neutral lipid p-ethoxy antisense and found a bunch of patents owned by the Board of Regents, University of Texas System. I assume these are the patents owned by BPTH.

The problem is that all of them claim priority back to either August 29, 1995 or October 4, 1996. 20 years from the August date means that the 1995 patents have all expired, as of this last August. The ones claiming priority to October 4, 1996 should expire this October.

I'm finally found one of the patents Brettj referred to and he is right that the priority date is July 8, 1996, meaning it should expire this July.

In any case, it really looks like any patent protection on the general delivery system is more or less expired, which means that there will be no opportunity to license it for other applications, but PN can keep on telling us that there is no need to hurry anything, even if we did miss the boat on a very valuable delivery system.

I'm just happy to finally see the pps moving in a positive direction. Lets all hope that PN can actually get a little motivation to work and move things at a better speed so we don't lose this momentum as a result of more missed deadlines.

Does he have an email address?

So I found this article about patent extensions under the Hatch-Waxman Act

http://corporate.findlaw.com/intellectual-property/patent-term-extensions-and-restoration-under-the-hatch-waxman-act.html

It refers to a specific statute, but the link is broken, so I searched for that statute. The very first lines of the statue say

"(a) The term of a patent which claims a product, a method of using a product, or a method of manufacturing a product shall be extended in accordance with this section from the original expiration date of the patent, which shall include any patent term adjustment granted under section 154(b), if—
(1) the term of the patent has not expired before an application is submitted under subsection (d)(1) for its extension;"

If the article I posted is correct, then an extension cannot be sought until the drug achieves FDA approval, but the statute specifically says that no extension is available if the patent has already expired. If the patents have already expired, or are about to expire, then a lack of FDA approval before expiration takes them out of any extensions.

So it looks like our frustrations with the inexcusable delays could also cost them patent protections that could otherwise be available.

That said, I could be completely off base here, because it seems like any FDA testing for the delivery system is a completely separate issue than the FDA process BPTH is currently going through for drug approval. I assume there has maybe already been some FDA approval on the delivery system, but I could be wrong.

Isn't the delivery system related to the patents that are all set to expire in the near future, or already expired? If that is the case, then there is, or will be, no option for licensing.

Its sad that I had the same thought that the only way this company will do anything is if PN or someone he cares about ends up with cancer.

Wow! lots of volume. I wonder if this means a lot of people have lost any faith in the leadership and are calling it quits.

I fear this company is going nowhere with the current management.

So you're saying that there is a chance that we have insider trading going on based on non-public information.

I didn't want to suggest it, but it does raise some eyebrows if suddenly there is an announcement here in the near future.

I honestly think this is another area that Peter is risking the company's future (in addition to his complete failure to perform an FDA trial). They avoid saying anything public for soooooooo long, but information is leaking out to people, which opens them up to insider trading liability. Peter needs to start announcing publicly the information he is sharing with people semi-privately.

If the safety study is done, make the announcement immediately. If the documentation has been submitted for phase two approval, then make the announcement immediately. Either that, or shut up until you do make the announcement public.

These are like fourth hand rumors, but lets be honest, anyone who follows this board could predict that we should at least be hearing about results from cohort 8 here in the not-to-distant future, and there is no reason to expect anything other than the results were positive. I mean, weren't we expecting to get results announced by the end of December, but they ended up having to do one more patient because one of the three they were testing died before finishing the tests?

On top of that, I personally have expectations that they should also have things ready to submit for starting phase II, so that wouldn't really be a big surprise either if it were announced here shortly.

A list of things that have been promised for a long time and we probably all expect in the short-term include:

cohort 8 results
A phase II plan and submission for approval from FDA
At least one new IND application
Maybe one or two new patent applications (or did they already announce that? It seems like this keeps getting talked about and I can't remember if they have actually done it.)

What am I missing.

Anyway, the point being that I think we would all consider it positive if we got news about even just 2 of these in the near future. If they can give us just one surprise, we would probably all be ecstatic for a couple of weeks, until we realize that we only have more missed deadlines to look forward to throughout the year.

It might have something to do with rumors I am hearing that there might be some positive announcements here in near future. Of course, the near future for BPTH might mean a month or even two, but I'm hearing rumors of positive news nonetheless.

I think the reason why Peter presents these is because he is convinced that he knows more about it than anyone else. His capabilities in his own mind are far greater than his capabilities in reality.

I honestly don't expect much change from the recent ups and downs with this stock until we have actually begun phase II. However, if current management is in place, then I sincerely anticipate a big jump with the announcement, followed by a stiff decline after a year or more passes without actually completing phase II.

Happy new year to all, and may BPTH make major progress this year (in spite of management).

This is exactly my point. Considering the technology behind this company and the path to a marketable drug, this company should never be a sell and buy and sell and buy company this coming year. It should be a buy and hold company. There are absolutely no good excuses for the delays encountered this year.

And lets be honest, of those that voted in favor, how much is owned directly by PN and other board members? Doesn't PN own like 8-9 million shares. There's 1/3 of the votes in favor of him. It's nice to see he thinks he is doing a good job.

Also, ILuv's report just substantiates what I have thought all along, most of those who support this board, and even those that went to the meeting have no idea at all how FDA approval and FDA trials work. Anyone with even a small understanding would recognize that these alleged difficulties that they claim to be facing can be VERY easily avoided or even completely eliminated with just a little bit of planning.

Is it true PN is making $500k plus stock options without any recourse for doing a poor job? I can't help but think about one of the greatest CEOs of our generation, Steve Jobs, who famously only made $1 a year in salary, but earned stock options and bonuses based on performance. Maybe PN needs to have his compensation restructured so he is paid more like Jobs. Something to incentivize progress instead of the status quo. What do you guys think?

Word on the street is those insiders and other very big shareholders are siding with PN still. I'm bummed. Like you, I have too much hope for the technology to cut and run, but I have little hope in management.

Too, I think there is always an argument that a delay should be explained publicly or that it shouldn't. Biopath seems to believe that it is best that these things be kept secret.

The following is based on my understanding, but could be clarified by others, since I seem to remember someone on this board has stated they have significant experience in clinical trials.

For phase 2 and phase 1 timing. Phase 1 is a safety study, where they basically find patients and give them a dosage to verify that it doesn't cause harm at that dosage. They incrementally increase the dosage to try and find the maximum dosage that is still safe to use (doesn't cause harm). All they have to do is enroll patients and give them the dosage at the amount for that stage of the study. As you have read on this board, that should be a fairly straightforward procedure that should only take a couple months for each dosage amount. As we have found, we have taken an entire year to do one dosage and they haven't given any explanation as to why. This suggests that it is just a failure in managing the study.

If my understanding is correct, after they finish all of these dosages and studies to the patients, they have to submit all of their data to the FDA. The FDA then reviews the data and approves or denies the completion of phase 1.

If approved, we move on to Phase 2, where Biopath has to submit their proposal for the phase 2 studies. They can't start until the proposal is approved by the FDA. Because you are working with a government agency, there will always be some significant amount of time to get approval of the phase 1 results and approval of the phase 2 study.

Only after they get approval can they then start working with several medical centers to start helping enroll patients and collect data.

I think this is why the major delays by biopath have most of us thinking that we probably won't even start phase 2 until end of 2016 or beginning of 2017. We have taken an entire year to do only 2 dosage amounts. We have moved so slowly thus far, without any explanation, that a reasonable person would assume that management won't get anything started for phase 2 until 2017.

In addition, the intellectual property on which they claim a lot of value does not have an indefinite lifetime. Patents are only good for 20 years from when they were filed.

I don't know what patents they have, but a simple search on google patents for "neutral lipid p-ethoxy antisense" pulls up a bunch of patents issued to the University of Texas System claiming priority back to Aug 1995, which means they are all expired now. If these are the patents that they claim protect their intellectual property, then they really did miss an opportunity.

I know PN has mentioned to several on this board that they are currently seeking new patents, but there is nothing public that has been assigned to Biopath.

Ugh! Of course there is room for an approved drug, but most first movers get a greater market share. The later you come, the less market share you typically get. This is basic stuff here. Does the CEO really not understand this?

I have to admit that I sincerely expected to have a product in the market by now, generating an income stream that would ensure the viability of the company.

So correct me if I'm wrong, but the news is basically that the technology is awesome, but management still sucks.

I spoke with a good friend yesterday who is the CEO of a very successful medium-sized business. He was telling me about how he has had to fire some of the people who were with the company when he started it about 6 or 7 years ago because it has outgrown their capabilities. He even talked about how he tries to be conscious about whether the company gets big enough that it outgrows his own capabilities, recognizing that at some point he could become a hindrance to its growth and progress.

It made me think of PN. I honestly think the company is bigger than he is capable of leading as CEO. He just doesn't have the skill set to move the company forward like it can and should. There has been almost no progress in 2 years. I'm convinced that every single person on this board could have taken over as CEO 2 and half years ago and done what PN has done in the last 2 years, and some of you probably would have done significantly better. He offers nothing to the progress of the company and, as already pointed out, is only an extreme financial cost to the company.

I seriously can't think of anything that he brings to the table that could not be easily replaced?

I suspect that the only way the momentum holds is if they make the next announcement. They have to keep making the promised announcements, or we will probably start to sink again.

How many of these 14 news releases that we will allegedly be getting in Q4 do you think will be like those two?

Unfortunately, I assume that the vast majority will be. I also assume that the rest will be primarily related to the patents that they are allegedly filing.

What that means is that most of the news will be more R&D based news and little or nothing about progress for any actual product to market. Without products to market, this company ends up just burning through cash.

There should have been at least one product brought to market by now, and anyone with experience with the FDA approval process will confirm this.

Does this mean they are expecting to be de-listed? The last time they were working with Roth Capital was back in 2012 for their help in wading through the OTC market.

http://www.reuters.com/article/2012/06/04/idUS140196+04-Jun-2012+BW20120604

One or two of those three positive things will be new drug announcements. I'm not positive about this, but I'm pretty confident based on what I've heard. Great! Now we can have 3 drugs in eternal clinical trials that will never be completed because they clearly don't know how to complete a clinical trial. Again, this just supports what I am saying, they are too focused on R&D with no focus on FDA approval and getting product to market. You have to have cash flow to survive and keep R&D alive.

The way you can tell this is good news is that the market is absolutely eating it up..........oh wait. Like Brett said, this was a whole bunch of nothing proving that the company has done nothing of value in the last 2 years. I'm on board with the fact that Peter has proven himself to be a horrible leader and needs to go ASAP. The longer we wait, the more of a chance this company ends up in the tank after getting beat out by competitors.

All of the info I am hearing suggests that Peter and his team are a bunch of researchers who are overly focused on doing more R&D at the expense of actually bringing anything to market. Without a leader who can focus on both aspects of a successful company, R&D and drug to market, BPTH will run out of funds and end up bankrupt. I honestly can't believe he is still in charge and giving himself raises.

SJ, they can't say much about the new targets because these are potentially patentable features and they haven't yet filed for patents and/or any applications aren't public yet. After they file for the patents, or after the applications are public (18 months after filing), then they will start talking more publicly about these new targets.

From other things I am hearing, things sound positive. My only concern is that they are identifying too many directions to go and are starting to run themselves too thin without any revenue streams. They really need to focus on the most advanced studies to get products into the market so they can start generating revenue. Then they can grow the company and advance these other potential products.

Do you think they are starting to really feel the pressure as the price continues to sink. I mentioned before, buy why can't we start emailing and asking them for an update on whether they have enrolled the patients for the new study. They don't need to give us any other info, but just verify that they are making the progress they promised

If I remember right, they should have enrolled the first patient on Feb. 9, and they said it would take 1 month. That means the first patient should have completed yesterday. They also said they would then enroll something like 3 more after the first. Maybe we should start emailing IR and asking for an update about whether they have completed patient 1 and whether they have enrolled the next patients. We don't need to ask for results, just news to verify proper progress.